Little Remedies New Baby Essentials
Acetaminophen, Simethicone, Zinc Oxide
Medtech Products Inc.
Human Otc Drug
NDC 63029-615Little Remedies New Baby Essentials also known as Acetaminophen, Simethicone, Zinc Oxide is a human otc drug labeled by 'Medtech Products Inc.'. National Drug Code (NDC) number for Little Remedies New Baby Essentials is 63029-615. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Little Remedies New Baby Essentials drug includes . The currest status of Little Remedies New Baby Essentials drug is Active.
Drug Information:
| Drug NDC: | 63029-615 |
| 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: | Little Remedies New Baby Essentials |
| 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: | Acetaminophen, Simethicone, Zinc Oxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Medtech Products Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| 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: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| 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 DRUG OTHER |
| 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: | 15 Feb, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 May, 2026 |
| 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: | 31 Dec, 2023 |
| 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: | Medtech Products Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 198857
307675
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | |
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 63029-615-01 | 1 KIT in 1 CARTON (63029-615-01) * 57 g in 1 TUBE * 59 mL in 1 BOTTLE * 15 mL in 1 BOTTLE * 30 mL in 1 BOTTLE * 59 mL in 1 BOTTLE | 15 Feb, 2017 | N/A | 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:
Purpose pain reliever / fever reducer
Purpose antigas
Product Elements:
Little remedies new baby essentials acetaminophen, simethicone, zinc oxide little remedies infant fever and pain reliever acetaminophen acetaminophen acetaminophen benzoic acid carboxymethylcellulose glycerin microcrystalline cellulose sucrose sodium benzoate water xanthan gum little remedies relief simethicone dimethicone dimethicone carboxymethylcellulose sodium citric acid monohydrate microcrystalline cellulose propylene glycol water sodium benzoate sucralose xanthan gum boudreauxs zinc oxide zinc oxide zinc oxide castor oil mineral oil paraffin balsam peru petrolatum beige gripe water ginger and fennel ginger ginger fennel fennel water agave tequilana juice glycerin citric acid monohydrate potassium sorbate xanthan gum clear saline saline water sodium chloride glycerin sodium phosphate, dibasic, anhydrous potassium phosphate, unspecified form benzalkonium chloride edetate disodium clear
Indications and Usage:
Uses temporarily: reduces fever relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or toothache.
Uses relieves discomfort of infant gas frequently caused by excessive swallowing of air or certain formulas or food
Uses âhelps loosen mucus secretions to aid aspiration and removal from nose and sinuses, allowing for easier breathing. for infants this can be assisted with the use of our specially designed âsoft tipâ nasal aspirator.
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if your child takes ⪠more than 5 doses in 24 hours, which is the maximum daily amount ⪠with other drugs containing acetaminophen. sore throat warning: if sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly. allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: ⪠skin reddening ⪠blisters ⪠rash. if a skin reaction occurs, stop use and seek medical help right away. do not use with any other products containing acetaminophen (prescription or non-prescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child is allergic to acetaminophen or any of the inactive ingredients in this product. ask a doc tor before use if the child has liver disease. ask a doctor or pharma cist before use if the
Read more...child is taking the blood thinning drug warfarin. when using this product do not exceed recommended dose (see overdose warning ) stop use and ask a doctor if new symptoms occur fever gets worse or lasts more than 3 days pain gets worse or lasts more than 5 days redness or swelling is present. these could be signs of a serious condition. keep out of reach of children. overdose warning: taking more than the recommended dose (overdose) can cause serious liver damage. in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away. prompt medical attention is critical even if you do not notice any signs or symptoms.
Warnings keep out of reach of children.
Warnings keep out of reach of children. ⪠the use of this dispenser by more than one person may spread infection. ⪠wipe nozzle clean after each use.
Do Not Use:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if your child takes ⪠more than 5 doses in 24 hours, which is the maximum daily amount ⪠with other drugs containing acetaminophen. sore throat warning: if sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly. allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: ⪠skin reddening ⪠blisters ⪠rash. if a skin reaction occurs, stop use and seek medical help right away. do not use with any other products containing acetaminophen (prescription or non-prescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child is allergic to acetaminophen or any of the inactive ingredients in this product. ask a doc tor before use if the child has liver disease. ask a doctor or pharma cist before use if the child is taking the blood thinning drug warfarin. when using this product do not exceed recommended dose (see overdose warning ) stop use and ask a doctor if new symptoms occur fever gets worse or lasts more than 3 days pain gets worse or lasts more than 5 days redness or swelling is present. these could be signs of a serious condition. keep out of reach of children. overdose warning: taking more than the recommended dose (overdose) can cause serious liver damage. in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away. prompt medical attention is critical even if you do not notice any signs or symptoms.
Warnings keep out of reach of children.
Warnings keep out of reach of children. ⪠the use of this dispenser by more than one person may spread infection. ⪠wipe nozzle clean after each use.
When Using:
When using this product do not exceed recommended dose (see overdose warning )
Dosage and Administration:
Directions this product does not contain directions or complete warnings for adult use. shake well before using find the right dose on the chart on the chart below. if possible, use weight to determine dose; otherwise, use age. only use the enclosed accusafe® syringe. do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child. remove cap, insert syringe to flow restrictor and invert bottle pull back syringe until filled to the prescribed level and slowly dispense the liquid into your childâs mouth (towards the inner cheek) if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in any 24-hour period (see overdose warning) do not give more than 5 days unless directed by a doctor replace cap tightly to maintain child resistance ml = milliliter weight (lbs) age (yrs) dose (ml) under 24 under 2 ask a doctor 24-35 2-3 5 ml
Directions â shake well before using â only use enclosed syringe; fill to prescribed level and dispense liquid slowly into childâs mouth, toward inner cheek â all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician. do not exceed 12 doses per day. â dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids â for best results, clean syringe after each use and replace original cap if possible, use weight to determine dose; otherwise use age. ml = milliliters age (yrs) weight (lbs) dose newborns & infants under 2 years under 24 0.3 ml children 2 years and over 24 and over 0.6 ml
Directions (for nasal use only) ⪠infants: 2 to 6 drops in each nostril as often as needed or as directed by your doctor. âªchildren: 2 to 6 sprays or drops into each nostril as often as needed or as directed by a doctor. store at 20°-25°c (68°-77°f). see bottle for lot and expiration date.
Stop Use:
Stop use and ask a doctor if new symptoms occur fever gets worse or lasts more than 3 days pain gets worse or lasts more than 5 days redness or swelling is present. these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel little remedies® new baby essentials kit infant fever/pain reliever acetaminophen / fever/pain reliever 2 fl oz (59 ml) syringe included gas drops simethicone /antigas 1 fl oz (30 ml) syringe included diaper rash ointment zinc oxide / skin protectant 2 oz (57 g) saline spray + drops 0.5 fl oz (15 ml) gripe water ginger / fennel supplement 2 fl oz (59 ml) syringe included nasal aspirator principal display panel little remedies® new baby essentials kit infant fever/pain reliever acetaminophen / fever/pain reliever 2 fl oz (59 ml) syringe included gas drops simethicone /antigas 1 fl oz (30 ml) syringe included diaper rash ointment zinc oxide / skin protectant 2 oz (57 g) saline spray + drops 0.5 fl oz (15 ml) gripe water ginger / fennel supplement 2 fl oz (59 ml) syringe included nasal aspirator