Otc - Active Ingredient
Active ingredient (in each chewable tablet)
Dextromethorphan HBr 10mg
Cvs Daytime Cough Relief Chews - Citrus Punch Chewable Gel
FDA Label NDC 51316-080
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 for the product Cvs Daytime Cough Relief Chews - Citrus Punch (NDC 51316-080). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Cough suppressant
Indications & Usage
Uses temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with a cold
Warnings
Warnings
Do not use if you are 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 an MAOI drug. If you do not knowif your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Otc - Ask Doctor
Ask a doctor before use if you have
- a sodium-restricted diet
- cough accompanied by excessive phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Otc - When Using
When using this product do not exceed recommended dosage
Otc - Stop Use
Stop use and ask doctor if
- cough persists for more than 7 days, 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.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Dosage & Administration
Directions
- take every 4 hours or as directed by a doctor
- chew thoroughly before swallowing
adults and children 12 years of age and over - 2 chewable tablets every 4 hours, not to exceed 12 chewable tablets in any 24-hour period
children ages 6 to 12 years - 1 chewable tablet every 4 hours, not to exceed 6 chewable tablets in any 24-hour period
children ages 6 and under - do not use
Other Safety Information
Other information
- each chewable tablet contains: potassium 5 mg and sodium 15 mg
- store in a cool dry place at 20° - 25°C (68° - 77°F)
Inactive Ingredient
Inactive ingredients: Anhydrous citric acid, beta carotene, corn syrup, glycerin, malic acid, medium chain triglycerides, natural & artificial flavors, pectin, sodium chloride, trisodium citrate (anhydrous), sucralose, sucrose, water.
Otc - Questions
Questions? 1-800-245-2898, Monday - Friday, 9AM - 4PM EST
* Please review the disclaimer below.
