Drkids Childrens Muti Symptom Cold Flu And Sore Throat Nighttime
Acetaminophen 325mg, Diphenhydraine Hcl 12.5mg, Phenylephrine Hcl 5mg
Calmco Llc
Human Otc Drug
NDC 73282-0114Drkids Childrens Muti Symptom Cold Flu And Sore Throat Nighttime also known as Acetaminophen 325mg, Diphenhydraine Hcl 12.5mg, Phenylephrine Hcl 5mg is a human otc drug labeled by 'Calmco Llc'. National Drug Code (NDC) number for Drkids Childrens Muti Symptom Cold Flu And Sore Throat Nighttime is 73282-0114. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Drkids Childrens Muti Symptom Cold Flu And Sore Throat Nighttime drug includes Acetaminophen - 325 mg/10mL Diphenhydramine Hydrochloride - 12.5 mg/10mL Phenylephrine Hydrochloride - 5 mg/10mL . The currest status of Drkids Childrens Muti Symptom Cold Flu And Sore Throat Nighttime drug is Active.
Drug Information:
| Drug NDC: | 73282-0114 |
| 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: | Drkids Childrens Muti Symptom Cold Flu And Sore Throat Nighttime |
| 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 325mg, Diphenhydraine Hcl 12.5mg, Phenylephrine Hcl 5mg |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Calmco Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| 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: | ACETAMINOPHEN - 325 mg/10mL
DIPHENHYDRAMINE HYDROCHLORIDE - 12.5 mg/10mL
PHENYLEPHRINE HYDROCHLORIDE - 5 mg/10mL
|
| 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: | OTC MONOGRAPH FINAL |
| 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, 2023 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 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. |
| Application Number: | part341 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| 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: | Calmco LLC
|
| 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. |
| UPC: | 0313992000324
|
| UPC stands for Universal Product Code. |
| UNII: | 362O9ITL9D
TC2D6JAD40
04JA59TNSJ
|
| 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: | Adrenergic alpha1-Agonists [MoA]
Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
alpha-1 Adrenergic Agonist [EPC]
|
| 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 |
|---|
| 73282-0114-6 | 16 VIAL, PLASTIC in 1 CARTON (73282-0114-6) / 10 mL in 1 VIAL, PLASTIC | 15 Feb, 2023 | 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:
Purposes pain reliever/fever reducer antihistamine/cough suppressant nasal decongestant
Product Elements:
Drkids childrens muti symptom cold flu and sore throat nighttime acetaminophen 325mg, diphenhydraine hcl 12.5mg, phenylephrine hcl 5mg citric acid monohydrate diphenhydramine hydrochloride diphenhydramine phenylephrine hydrochloride phenylephrine trisodium citrate dihydrate sodium metabisulfite edetate disodium sodium benzoate glycerin propylene glycol polyethylene glycol 600 acetaminophen acetaminophen sorbitol solution 70% maltitol water sucralose
Indications and Usage:
Uses â temporarily relieves these common cold and flu symptoms: â minor aches and pains â headache â sore throat â nasal congestion â runny nose â sneezing â cough â controls cough to help your child get to sleep â temporarily reduces fever
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if your child takes â more than 5 doses in 24 hours, which is the maximum daily amount for this product â with other drugs containing acetaminophen. allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: â skin reddening â blisters â rash. if a skin reaction occurs, stop use and seek medical help right away. sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use â with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist â to make a child sleepy â with any other product containing diphenhydramine, even one used on the skinâ if a child who is taking a prescription monoamine oxidase inhi
Read more...bitor (maoi) (certain drugs for depression, psychiatric or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the maoi drug. if you do not know if your child's prescription drug contains an maoi, ask a doctor or pharmacist before giving this product. ask a doctor before use if your child has â liver disease â high blood pressure â heart disease â diabetes â thyroid diseaseâ glaucoma â a breathing problem such as chronic bronchitis â persistent or chronic cough such as occurs with asthma â cough that occurs with too much phlegm (mucus) ask a doctor or pharmacist before use if your child is â taking the blood thinning drug warfarin â taking any other nasal decongestant or stimulant â taking any other pain reliever/ fever reducer â taking sedatives or tranquilizers when using this product â do not exceed recommended dosage (see overdose warning) â excitability may occur, especially in children â marked drowsiness may occur â sedatives and tranquilizers may increase the drowsiness effect stop use and ask a doctor if â nervousness, dizziness, or sleeplessness occur â pain, nasal congestion or cough gets worse or lasts more than 5 days â fever gets worse or lasts more than 3 days â redness or swelling is present â new symptoms occur â cough comes back or occurs with fever, rash, or persistent headache. these could be signs of a serious condition. keep out of reach of children overdose warning taking more than the recommended dose (overdose) may cause liver damage. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical even if you do not notice any signs or symptoms
Do Not Use:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if your child takes â more than 5 doses in 24 hours, which is the maximum daily amount for this product â with other drugs containing acetaminophen. allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: â skin reddening â blisters â rash. if a skin reaction occurs, stop use and seek medical help right away. sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use â with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist â to make a child sleepy â with any other product containing diphenhydramine, even one used on the skinâ if a child who is taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the maoi drug. if you do not know if your child's prescription drug contains an maoi, ask a doctor or pharmacist before giving this product. ask a doctor before use if your child has â liver disease â high blood pressure â heart disease â diabetes â thyroid diseaseâ glaucoma â a breathing problem such as chronic bronchitis â persistent or chronic cough such as occurs with asthma â cough that occurs with too much phlegm (mucus) ask a doctor or pharmacist before use if your child is â taking the blood thinning drug warfarin â taking any other nasal decongestant or stimulant â taking any other pain reliever/ fever reducer â taking sedatives or tranquilizers when using this product â do not exceed recommended dosage (see overdose warning) â excitability may occur, especially in children â marked drowsiness may occur â sedatives and tranquilizers may increase the drowsiness effect stop use and ask a doctor if â nervousness, dizziness, or sleeplessness occur â pain, nasal congestion or cough gets worse or lasts more than 5 days â fever gets worse or lasts more than 3 days â redness or swelling is present â new symptoms occur â cough comes back or occurs with fever, rash, or persistent headache. these could be signs of a serious condition. keep out of reach of children overdose warning taking more than the recommended dose (overdose) may cause liver damage. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical even if you do not notice any signs or symptoms
When Using:
When using this product â do not exceed recommended dosage (see overdose warning) â excitability may occur, especially in children â marked drowsiness may occur â sedatives and tranquilizers may increase the drowsiness effect
Dosage and Administration:
Directions â this product does not contain directions or complete warnings for adult use â do not give more than directed (see overdose warning) â dose as follow or as directed by a doctor. â follow the instructions under "easy to use" on the side panel â empty all liquid in each single-use vial when dosing â children 6 - 11 years of age: 1 single-use vial (10ml) every 4 hours while symptoms last; do not give more than 5 doses in any 24 hour period â children under 6 years of age: do not use dosing chart age (years) dose (ml) 6 - 11 years 1 single-use vial (10ml) every 4 hours. do not give more than 5 times in 24 hours.
Stop Use:
Stop use and ask a doctor if â nervousness, dizziness, or sleeplessness occur â pain, nasal congestion or cough gets worse or lasts more than 5 days â fever gets worse or lasts more than 3 days â redness or swelling is present â new symptoms occur â cough comes back or occurs with fever, rash, or persistent headache. these could be signs of a serious condition.
Overdosage:
Overdose warning taking more than the recommended dose (overdose) may cause liver damage. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical even if you do not notice any signs or symptoms
Package Label Principal Display Panel:
Package label package
Further Questions:
Questions or comments? call 941-202-3207 or visit www.drkids.com