Active Ingredients (In Each 10 Ml)
Brompheniramine maleate, 2 mg
Dextromethorphan HBr, 10 mg
Phenylephrine HCl , 5 mg
Childrens Dimetapp Cold And Cough Liquid
FDA Label NDC 51316-645
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Childrens Dimetapp Cold And Cough (NDC 51316-645). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each 10 ml), purposes, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Antihistamine
Cough suppressant
Nasal decongestant
Uses
▪ temporarily relieves:▪ Nasal congestion▪ runny nose▪ cough▪ sneezing▪ itchy, watery eyes due to hay fever▪ itching of the nose or throat
▪ temporarily restores freer breathing through the nose
Do Not Use
▪ to sedate a child or to make a child sleepy▪ if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If You Have
▪ heart disease▪ high blood pressure▪ thyroid disease▪ diabetes▪ trouble urinating due to an enlarged prostate gland▪ glaucoma▪ cough that occurs with too much phlegm (mucus)▪ a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
▪ taking any other oral nasal decongestant or stimulant▪ taking sedatives or tranquilizers
When Using This Product
▪ do not use more than directed▪ may cause marked drowsiness▪ avoid alcoholic beverages▪ alcohol, sedatives, and tranquilizers may increase drowsiness▪ be careful when driving a motor vehicle or operating machinery▪ excitability may occur, especially in children
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occurs
- symptoms do not get better within 7 days or are accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Directions
▪ do not take more than 6 doses in any 24-hour period▪ measure only with dosage cup provided▪ keep dosage cup with product▪ ml = milliliter
| age | dose |
|---|---|
adults and children 12 years and over | 20 ml every 4 hours |
children 6 to under 12 years | 10 ml every 4 hours |
children under 6 years | do not use |
Other Information
- each 10 ml contains: sodium 6 mg
- store at room temperature.
Inactive Ingredients
anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, artificial flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose
Questions Or Comments?
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Compare to the active ingredients in Children’s Dimetapp® Cold & Cough*
NDC 51316-645-08
Children's
Cold
& Cough
Brompheniramine maleate (Antihistamine)
Dextromethorphan HBr (Cough Suppressant)
Phenylephrine HCl (Nasal Decongestant)
Relieves Nasal Symptoms
- Stuffy Nose
- Runny Nose
- Sneezing
- Itchy, Watery Eyes
- Cough
Plus Other Symptoms
For Ages 6 Years and Over
Grape Flavor
Naturally and Artificially Flavored
8 FL OZ (236 ml)
Distributed by:
*This product is not distributed by Foundation Consumer Brands, LLC, the distributor of Children’s Dimetapp® Cold & Cough*.
Cvs Children's Cold & Cough 236 mL (Dimetapp 02)
* Please review the disclaimer below.
