Children’S Cold & Cough Active Ingredients (In Each 10 Ml)
Brompheniramine maleate, 2 mg
Dextromethorphan HBr, 10 mg
Cvs Pharmacy Kit
FDA Label NDC 51316-635
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, Inc. for the product Cvs Pharmacy (NDC 51316-635). 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 children’s cold & cough active ingredients (in each 10 ml), children’s nighttime cold & coughactive ingredients (in each 10 ml), purposes for children’s cold & cough, purposes for children’s nighttime cold & cough, uses, warnings do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Children’S Nighttime Cold & Coughactive Ingredients (In Each 10 Ml)
Diphenhydramine HCL12.5 mg
Purposes For Children’S Cold & Cough
Antihistamine
Cough suppressant
Purposes For Children’S Nighttime Cold & Cough
Antihistamine/Cough suppressant
Uses
Cold & Cough
▪ temporarily relieves▪ runny nose▪ cough▪ sneezing▪ itching of the nose or throat▪ itchy, watery eyes due to hay fever (or other upper respiratory allergies)▪ temporarily alleviates the intensity of coughing
▪ temporarily relieves▪ runny nose▪ cough▪ sneezing▪ itching of the nose or throat▪ itchy, watery eyes due to hay fever (or other upper respiratory allergies)▪ relieves the impulse to cough to help you sleep.
Nighttime Cold & Cough
Warnings Do Not Use
Cold & Cough
▪ 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.▪ to sedate a child or to make a child sleepy▪ With any other product containing diphenhydramine, even one used on skin
Nighttime Cold & Cough
Ask A Doctor Before Use If You Have
Cold & Cough
▪ trouble urinating due to an enlarged prostate gland▪ glaucoma▪ cough that occurs with too much phlegm (mucus)▪ a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema.▪ trouble urinating due to an enlarged prostate gland▪ glaucoma▪ cough that occurs with too much phlegm (mucus)▪ a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
Nighttime Cold & Cough
Ask A Doctor Or Pharmacist Before Use If You Are
Cold & Cough
taking sedatives or tranquilizers
Nighttime Cold & Cough
taking sedatives or tranquilizers
When Using This Product
Cold & Cough
▪ do not use more than directed.▪ may cause marked drowsiness▪ avoid alcoholic drinks▪ alcohol, sedatives and tranquilizers may increase drowsiness▪ be careful when driving a motor vehicle or operating machinery▪ excitability may occur, especially in children▪ do not use more than directed.▪ may cause marked drowsiness▪ avoid alcoholic drinks▪ alcohol, sedatives and tranquilizers may increase drowsiness▪ be careful when driving a motor vehicle or operating machinery▪ excitability may occur, especially in children
Nighttime cold & cough
Stop Use And Ask A Doctor If
Cold & Cough
cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.
These could be signs of a serious condition.
Nighttime cold & cough
cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.
These could be signs of a serious condition.
Keep Out Of Reach Of Children.
Cold & Cough
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Nighttime Cold & Cough
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
If Pregnant Or Breast-Feeding,
Ask a health professional before use
Directions
Cold & Cough
▪ do not take more than 6 doses in any 24-hour period▪ measure only with dosing cup provided.▪ Keep dosage cup with product▪ mL= milliliter▪ do not take more than 6 doses in any 24-hour period▪ measure only with dosing 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 |
Nighttime cold & cough
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
Cold & cough
▪ each 10 mL contains: sodium 6 mg▪ store at room temperature.▪ each 10 mL contains: sodium 6 mg▪ store at room temperature.
Nighttime cold & cough
Inactive Ingredients
Inactive ingredients for Cold & Cough
citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose
Inactive ingredients for Nighttime
citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose
Questions Or Comments?
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Compare to the active ingredients in Children's Dimetapp® Cold & Cough*
Children's
Cold & Cough
Brompheniramine Maleate (Antihistamine),
Dextromethorphan HBr (Cough Suppressant)
Relieves + comforts
- Runny nose
- Itchy, watery eyes
- Sneezing
- Cough
- Runny nose
- Itchy, watery eyes
- Sneezing
- Cough
For Ages 6 Years and over
No Added Alcohol
Grape Flavor
Naturally and Artificially Flavored
Compare to the active ingredients in Children's Dimetapp® Nighttime Cold & Congestion**
Children's Nighttime
Cold & Cough
Diphenhydramine HCI (Antihistamine / Cough Suppressant)
Relieves + comforts
For Ages 6 Years and over
No Added Alcohol
Grape Flavor
Naturally and Artificially Flavored
2-4 FL OZ (118 mL) BOTTLES/TOTAL 8 FL OZ (236 mL)
Do not take both products at the same time. Always wait at least 4 hours before taking another dose of the product.
TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING
IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE FOR FULL LABELING
*This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC, the distributor of Children's Dimetapp® Cold & Cough.
**This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC, the distributor of Children's Dimetapp® Nighttime Cold & Cough.
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