Colic Calm Plus
Aloe, Asafoetida, Carbo Vegetabilis, Carum Carvi, Chamomilla, Cinchona Officinalis, Foeniculum Vulgare, Magnesia Phosphorica, Melissa Officinalis, Mentha Piperita, Prunus Spinosa, Zingiber Officinale
Tjl Enterprises Inc.
Human Otc Drug
NDC 13992-002Colic Calm Plus also known as Aloe, Asafoetida, Carbo Vegetabilis, Carum Carvi, Chamomilla, Cinchona Officinalis, Foeniculum Vulgare, Magnesia Phosphorica, Melissa Officinalis, Mentha Piperita, Prunus Spinosa, Zingiber Officinale is a human otc drug labeled by 'Tjl Enterprises Inc.'. National Drug Code (NDC) number for Colic Calm Plus is 13992-002. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Colic Calm Plus drug includes Activated Charcoal - 1 [hp_X]/mL Aloe - 8 [hp_X]/mL Caraway Oil - 3 [hp_X]/mL Chamomile - 3 [hp_X]/mL Cinchona Officinalis Bark - 3 [hp_X]/mL Fennel Seed - 3 [hp_X]/mL Ferula Assa-foetida Resin - 3 [hp_X]/mL Ginger - 3 [hp_X]/mL Magnesium Phosphate, Dibasic Trihydrate - 8 [hp_X]/mL Melissa Officinalis - 3 [hp_X]/mL and more. The currest status of Colic Calm Plus drug is Active.
Drug Information:
| Drug NDC: | 13992-002 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Colic Calm Plus |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Aloe, Asafoetida, Carbo Vegetabilis, Carum Carvi, Chamomilla, Cinchona Officinalis, Foeniculum Vulgare, Magnesia Phosphorica, Melissa Officinalis, Mentha Piperita, Prunus Spinosa, Zingiber Officinale |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Tjl Enterprises Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ACTIVATED CHARCOAL - 1 [hp_X]/mL ALOE - 8 [hp_X]/mL CARAWAY OIL - 3 [hp_X]/mL CHAMOMILE - 3 [hp_X]/mL CINCHONA OFFICINALIS BARK - 3 [hp_X]/mL FENNEL SEED - 3 [hp_X]/mL FERULA ASSA-FOETIDA RESIN - 3 [hp_X]/mL GINGER - 3 [hp_X]/mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE - 8 [hp_X]/mL MELISSA OFFICINALIS - 3 [hp_X]/mL
Load more...MENTHA PIPERITA - 3 [hp_X]/mL PRUNUS SPINOSA FLOWER BUD - 3 [hp_X]/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED HOMEOPATHIC |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 13 Dec, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 11 Feb, 2024 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 06 May, 2026 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | TJL Enterprises Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000185375 N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0008672
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 2P3VWU3H10 V5VD430YW9 C2J9B08Q3I FGL3685T2X S003A158SB G3QC02NIE6 W9FZA51AS1 C5529G5JPQ HF539G9L3Q YF70189L0N
Load more...79M2M2UDA9 53Y84VPS2W
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class EPC: | Non-Standardized Plant Allergenic Extract [EPC] Non-Standardized Food Allergenic Extract [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Increased Histamine Release [PE] Cell-mediated Immunity [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class CS: | Allergens [CS] Dietary Proteins [CS] Plant Proteins [CS] Food Additives [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Allergens [CS] Calculi Dissolution Agent [EPC] Cell-mediated Immunity [PE] Dietary Proteins [CS] Food Additives [CS] Increased Histamine Release [PE] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Inhibition Small Intestine Fluid/Electrolyte Absorption [PE] Magnesium Ion Exchange Activity [MoA] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Osmotic Activity [MoA] Osmotic Laxative [EPC] Plant Proteins [CS] Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 13992-002-01 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (13992-002-01) / 59 mL in 1 BOTTLE, WITH APPLICATOR | 13 Dec, 2016 | 11 Feb, 2024 | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Uses: temporarily relieves the symptoms of infant:* ⢠gas ⢠colic ⢠upset stomach ⢠bloating ⢠hiccups *these statements are based upon traditional homeopathic practice. they have not been reviewed by the food and drug administration.
Product Elements:
Colic calm plus aloe, asafoetida, carbo vegetabilis, carum carvi, chamomilla, cinchona officinalis, foeniculum vulgare, magnesia phosphorica, melissa officinalis, mentha piperita, prunus spinosa, zingiber officinale aloe aloe ferula assa-foetida resin asafetida activated charcoal activated charcoal caraway oil caraway oil chamomile chamomile cinchona officinalis bark cinchona officinalis bark fennel seed fennel seed magnesium phosphate, dibasic trihydrate magnesium cation melissa officinalis melissa officinalis mentha piperita mentha piperita prunus spinosa flower bud prunus spinosa flower bud ginger ginger citric acid monohydrate glycerin potassium benzoate potassium citrate potassium sorbate water xylitol
Indications and Usage:
Indications: temporarily relieves the symptoms of infant:* ⢠gas ⢠colic ⢠upset stomach ⢠bloating ⢠hiccups *these statements are based upon traditional homeopathic practice. they have not been reviewed by the food and drug administration.
Warnings:
Warnings: ⢠do not use if outer seal imprinted with colic calm logo on glass bottle or protective wrap on oral dispenser is broken or missing. ⢠stop use and consult a doctor i f symptoms last more than 7 days or inflammation, fever or infection occurs. â¢as with all medications, it is important to ensure that your child's medical professional is aware of the use of this product. â¢because product is black, a temporarily, harmless, darkening of the stool may occur. â¢may stain fabric; protect clothing and furniture.
Dosage and Administration:
Directions: weight dose under 20 lbs. 1/4 teaspoon (1.25 ml) over 20 lbs. 1/2 teaspoon (2.5 ml) shake well before use to obtain uniform dark mixture. remove outer seal imprinted with colic calm logo from glass bottle and protective wrap on oral dispenser. when symptoms occur, fill enclosed oral dispenser up to indicated dose level and dispense liquid slowly, drop-by-drop into mouth, between cheek and gums. if needed, repeat every 60 minutes for up to 3 doses, or as directed by a physician. do not exceed 4 full doses in 24 hours. recap glass bottle and clean oral dispenser.
Spl Patient Package Insert:
Patient information insert: natural relief when it's needed most* thank you for choosing colic calm, the first homeopathic gripe water for the treatment of colic, gas and upset stomach. while original colic calm combines nine homeopathic ingredients, colic calm plus includes three additional homeopathic remedies. it is recommended by pediatricians, natural health care practitioners, and pharmacists. colic calm plus® is: ⢠safe, gentle and effective ⢠non-habit forming ⢠a smart alternative to conventional drugs frequently asked questions** what is the purpose of colic calm plus? colic calm plus homeopathic medicine provides relief for discomfort from gas, colic, upset stomach, and even hiccups in infants. importantly, colic calm plus is made according to good manufacturing practices (gmp) for over-the-counter homeopathic medicines. is colic calm plus safe for my baby? colic calm plus is a combination of twelve homeopathic remedies, each of which has a long history of
Read more...safe use. the proprietary formula is non-habit forming and does not contain sugar, sodium bicarbonate, simethicone, herbal oils, soy, dairy, wheat, gluten, yeast, animal products, artificial flavors or colors. what makes colic calm plus different from other colic preparations? the active ingredients in colic calm plus provide multi-symptom relief to quickly soothe babyâs digestive system. according to the principles of homeopathy, each dose gently stimulates the bodyâs ability to heal itself, as opposed to merely suppressing symptoms. how long does colic calm plus take to work? most babies experience relief with their first dose of colic calm plus. however, some may take longer before showing noticeable improvement. we recommend giving colic calm plus up to one week to fully work its wonders. keep in mind that many babies simply have trouble calming down once the crying cycle has begun, so it is recommended to administer colic calm plus at the first signs of discomfort. we encourage you to email us at customercare@coliccalm.com or call us at (877) 321-calm for helpful customized suggestions that can make a difference. what are the directions for use? at the first signs of digestive discomfort, shake glass bottle to obtain a uniform dark mixture. fill enclosed oral dispenser and dispense liquid slowly, drop-by-drop , into mouth, between cheek and gums. do not dispense faster than baby can comfortably swallow. if needed, repeat once every 60 minutes for up to 3 doses, or as directed by a physician. do not exceed the equivalent of 4 full doses for the appropriate weight category per day. carefully recap bottle, clean oral dispenser and let air-dry after each use. what if my baby spits up colic calm plus? some spitting up is normal. one factor is temperature. some babiesâ stomachs are sensitive to cooler liquids, so colic calm plus at room temperature could be unsettling. colic calm plus may be added to a small amount (1 or 2 ounces) of warmed formula or pumped breast milk to raise temperature and change the taste and texture back to something familiar. every baby is different, so a little trial and error is sometimes needed. it is best to avoid giving colic calm plus immediately after feeding if babyâs stomach is full, as spit-up may occur from the added pressure. can my baby take other medications while using colic calm plus? as with all medications, it is important to ensure that your doctor is aware of the use of this product. always check with your doctor if your baby is taking other medications or has been treated for health concerns. if other medications are being used, allow a two-hour window between the other medication and colic calm plus, so that the effects of the other medication are not lessened. does colic calm plus have any side effects? there are no known contraindications to any of the active ingredients in colic calm plus. however, it is always advised that you check with your doctor before introducing any product. you may notice a temporary, harmless, darkening of the stool. this occurs because colic calm plus uses a form of carbon called carbo vegetabilis (vegetable charcoal). this pure, naturally-derived, non-carcinogenic vegetable charcoal makes colic calm plus black in color. vegetable charcoal does not enter the bloodstream, and passes out of the body naturally and easily, along with the gas and toxins it has collected on its journey through the digestive tract. what is the best way to get out stains? the rich dark color of colic calm plus is as mother nature intended, without any "pretty" coloring to alter its purity and efficacy. while the microfine particles of vegetable charcoal do not contain any dye, they can get lodged in fabrics and may require gentle manipulation to loosen. this is why we have included a stain warning on bottle and box. we find that stains lift out easily with most spray stain removers. it is best to treat stains promptly. for stubborn stains, try pre-spotting with dishwashing liquid before washing. many parents keep bibs and rags handy, so that stain removal doesnât become an issue. can colic calm plus be used for anything other than colic? yes. colic calm plus is helpful in easing pain associated with stomach upset. many toddlers and older children benefit from stomach ache relief with colic calm plus. colic calm plus can also provide relief for flatulence and bloating from gas. in addition, a great number of parents swear by colic calm plus for effective treatment of hiccups. how long should each bottle last? each bottle contains (47) ¼ teaspoon (1.25 ml) doses for babies under 20 lbs. or (24) ½ teaspoon (2.5 ml) doses for those over 20 lbs. some children require more doses than others, depending on the frequency of their symptoms. discard bottle within three months after opening. how do i store colic calm plus? this product should be stored at room temperature, out of direct sunlight. because there is no need for refrigeration, colic calm plus is also ideal for traveling away from home. why does my baby sleep soundly and longer after taking colic calm plus? peaceful sleep often follows naturally after relief. there are no narcotic, sedative or habit-forming ingredients in colic calm plus. what is "colic"? colic is defined as inconsolable crying that lasts for more than 3 hours per day for at least 3 days per week. colic is a self-limiting condition that typically resolves by 4 months of age. most experts point to gastrointestinal discomfort as the cause, due to the immaturity of a babyâs digestive system: i. "intestinal hyperperistalsis is one part of the clinical picture in infantile colic." - motilin, vasoactive intestinal peptide and gastrin in infantile colic by l. lothe, md, s. a. ivarsson, md, and t. lindberg ii. "various factors act in tandem, leading to disturbances in infant gastrointestinal motility that manifests clinically as colic." - is colic a gastrointestinal disorder? by gupta, sandeep k. , m.d. * all active ingredients are derived from natural sources. ** these statements are based upon traditional homeopathic practice. they have not been reviewed by the food and drug administration. iii. "observation of colicky infants has suggested a gastrointestinal origin for this discomfort." - efficacy of herbal tea preparation in infantile colic by zvi weizman, md, soliman alkrinawi, m.d., dan goldfarb, m.d., and chairn bitran, m.d. homeopathy and dilutions the homeopathic ingredients in colic calm plus are diluted either to 1x, 3x or 8x potency. a 1x dilution is obtained by mixing 1 part of the medicinal ingredient with 9 parts of a neutral diluting agent then vigorously shaking the solution (succussion). the 3x is obtained by repeating this dilution and succussion process 3 times. nine of the twelve active ingredients in colic calm plus operate according to homeopathic principles at a 3x potency, 1 part per 1,000, or 0.1%. this level of dilution is found in some non-homeopathic pharmaceuticals in use today. drugs such as, ergocalciferol, are much more diluted than 1 part per 1000. unlike most drugs, homeopathic products are not subject to pre-market approval by the food and drug administration (fda) and are not reviewed by the fda. the fda has not evaluated this product. activated charcoal colic calm plus derives its rich black color from carbo vegetabilis 1x (also known as activated charcoal or medicinal carbon). a 1x dilution is a dilution of one part per 10. the activated charcoal in colic calm plus is prepared according to hpus methods. charcoal has been used safely in medicinal applications for thousands of years. the activated charcoal in colic calm plus relieves the bloating and abdominal discomfort attributable to gaseousness in colicky babies. charcoal's efficacy in adsorbing gases and toxins in the digestive system has been established in several studies and medical texts including: i. "activated charcoal also significantly reduced the number of volunteers having abdominal symptoms and the symptom score. our data clearly indicates that activated charcoal is an effective anti-gas medication. simethicone, also commonly prescribed for gaseousness, was not found to be effective." - activated charcoal, simethicone, and intestinal gas: a double - blind study by naresh k. jain, m.d., vijay p. patel, m.d., and c. s. pitchumoni, m.d. ii. "these experiments showed that orally administered activated charcoal was effective in preventing the large increase in the number of flatus events and increased breath hydrogen concentrations that normally occur following a gas-producing meal." - effects of orally administered activated charcoal on intestinal gas by r.j. hall, e. thompson, and a. strother. iii. "symptoms of bloating and abdominal cramps attributable to gaseousness were also significantly reduced in both groups by activated charcoal." - efficacy of activated charcoal in reducing intestinal gas: a double - blind clinical trial by jain nk, m.d., patel vp, m.d., pitchumoni cs, m.d. iv. "the use of activated charcoal for adsorbing intestinal gas has been effective in healthy subjects" â gastrointestinal gas. fardy j, sullivan s. v. "activated charcoal or prokinetic agents also can be effective options in some patients for intestinal gas." - intestinal gas by fink rn, lembo aj. vi. "the improvement was still evident 2 months after the end of treatment." - efficacy of an activated charcoal / simethicone combination in dyspeptic syndrome: results of a randomized prospective study in general practice. lecuyer m, cousin t, monnot mn, coffin b. each dose of colic calm plus contains amounts of activated charcoal corresponding to the amounts used in these efficacy studies, adjusting for the size of the baby. i. "a child's drug dose may be weight (in kg) times 2% of an adult dose" - calculation of drug dosage and body surface area of children. j a lack and m e stuart-taylor does colic calm work? while no product can claim to work for everyone, colic calm does have an impressive track record. visit our website www.coliccalm.com/video/ to view "seeing is believing" videos of parents using our products with immediate results. also, check out hundreds of five star reviews on amazon.com and read "one mom's story" customer interviews at journal.coliccalm.com. many pediatricians and medical professionals also recommend our products: "colic calm incorporates natural ingredients to reduce colic symptoms ⦠i frequently recommend colic calm for my patients because it provides safe, natural relief for symptoms of colic. our parentsâ feedback has been tremendously positive and our patientsâ symptoms have improved in almost all instances." - steven e. rahman, m.d., pediatrician, lake worth, florida "colic calm has really been an excellent treatment for my patients with colic. l have mothers giving me positive feedback on how wonderful colic calm has been in relieving colic symptoms in infants of all ages. i even used the product on my own grandson with great results!" - roger mendoza, m.d., pediatrician, beaumont, texas "colic calm had a soothing effect on my baby... iâve not seen anything so amazing as colic calm. what a valuable breakthrough." - geneva lejeune, m.d., pediatrician, shreveport, louisiana we fully stand behind our product with our money-back guarantee, but realize that not every baby will experience relief from colic calm plus. we encourage you to contact our colic calm plus customer care team for customized suggestions that can make a difference. cease using the product if you do not see noticeable improvement within one week. your baby simply may not have common âcolicâ, or the condition may be one that colic calm plus cannot treat. contact your local point-of-purchase retailer for an immediate refund. if your retailer does not provide a refund, contact us for a full refund of the purchase price. just send us a copy of the receipt within 30 days of purchase along with the unused portion and we will refund your purchase and shipping costs. please visit www.coliccalm.com/refund for full details on our refund policy. refunds available to us customers only. do not use colic calm plus to treat other medical conditions not indicated on the product packaging. colic calm plus should not be used to treat chronic conditions, conditions that are not self-limiting or conditions that require a doctorâs diagnosis. conditions unrelated to colic that may cause a baby to exhibit discomfort include, but are not limited to, lactose intolerance, cowâs milk allergy, gastrointestinal infections or infections of any kind, allergies or sensitivities. always consult your doctor concerning your babyâs health condition and the use of this or any other medicine. learn more about colic calm plus® visit coliccalm.com or contact us directly: email customercare@coliccalm.com phone (877) 321-calm win $2,500 for your home video share a home video of colic calm plus helping your baby and if your video is selected you will receive $2,500. many will enter, many will win! for easy-to-follow directions visit: coliccalm.com/homevideo * all active ingredients are derived from natural sources. ** these statements are based upon traditional homeopathic practice. they have not been reviewed by the food and drug administration. extra support ⢠enhanced formula
Package Label Principal Display Panel:
Package label display: homeopathic medicine ndc 13992-002-01 colic calm® plus extra support ⢠enhanced formula for symptomatic relief of infant gas⢠colic⢠upset stomach fast acting safe & gentle natural relief even treats hiccups 24 - 47 doses ⢠oral suspension ⢠2 fl. oz. (59 ml) colic calm plus lbl colic calm plus ctn
Further Questions:
Questions: distributed by tjl enterprises, inc. long beach, ca 90803 coliccalm.com ⢠(877) 321â¢calm