FDA Label for Equate Kids Daytime Dex Cough Gels
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - ASK DOCTOR
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Equate Kids Daytime Dex Cough Gels Product Label
The following document was submitted to the FDA by the labeler of this product Walmart. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient (in each chewable tablet)
Dextromethorphan HBr 10 mg
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 now taking a prescription monoamine axidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 week 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.
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 under 6 - 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° to 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? 1-888-287-1915
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