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Drug Facts
Cvs Nighttime Childrens Solution
FDA Label NDC 51316-752
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 Cvs Nighttime Childrens (NDC 51316-752). 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 other, otc - purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, 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
Otc - Purpose
| Active ingredients (in each 15 mL) | Purpose |
|---|---|
Chlorpheniramine maleate 2 mg | Antihistamine |
Dextromethorphan HBr 15 mg | Cough suppressant |
Uses
temporarily relieves cold symptoms:
▪ cough due to minor throat & bronchial irritation▪ sneezing▪ runny nose
Do Not Use
▪ 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.▪ to make a child sleepy
Ask A Doctor Before Use If You Have
▪ glaucoma▪ cough that occurs with too much phlegm (mucus)▪ a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema▪ trouble urinating due to enlarged prostate gland
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
When Using This Product
▪ excitability may occur, especially in children▪ marked drowsiness may occur▪ avoid alcoholic drinks▪ be careful when driving a motor vehicle or operating machinery▪ alcohol, sedatives, & tranquilizers may increase drowsiness
Stop Use And Ask A Doctor If
▪ cough persists more than 1 week, tends to recur or is accompanied by fever, rash, or persistent headache.
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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
▪ take only as directed▪ do not exceed 4 doses per 24 hrs.▪ only use the dose cup provided
adults & children 12 yrs & over | 30 mL every 6 hrs. |
children 6 to under 12 yrs | 15 mL every 6 hrs. |
children 4 to under 6 yrs | do not use unless directed by a doctor |
children under 4 yrs | do not use |
Other Information
▪ each 15 mL contains: potassium 5 mg, sodium 5 mg▪ sugar free▪ aspirin free▪ store at room temperature
Inactive Ingredients
anhydrous citric acid, FD&C Red No. 40, flavor, potassium citrate, potassium sorbate, propylene glycol, purified water, sodium benzoate, sorbitol, sucrose
Questions Or Comments?
1-866-467-2748
Principal Display Panel - 236 Ml Bottle Label
Compare to the active ingredients in Children’s Vicks Nyquil™ Cold & Cough*
NDC 51316-752-08
Nighttime
Childrens
Cold & Cough
Chlorpheniramine maleate 2 mg,
Dextromethorphan HBr 15 mg
- Sneezing
- Runny Nose
- Cough
No Added Alcohol, Acetaminophen Free
Berry Flavor
Naturally and Artificially Flavored
8 FL OZ (236 ml)
DISTRIBUTED BY:
TAMPER EVIDENT: Do not use if printed shrink band is missing or broken.
*This product is not manufactured or distributed by Procter & Gamble, the distributor of Children’s Vicks® Nyquil™ Cold & Cough.
Cvs Nighttime Children's Cold And Cough Berry Flavor (Nyquil 01)
* Please review the disclaimer below.
