FDA Label for Cough Out
View Indications, Usage & Precautions
Cough Out Product Label
The following document was submitted to the FDA by the labeler of this product Efficient Laboratories Inc.. 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 teaspoonful 5 mls) Purpose
Guiafenesin 100 mg (USP)............................................Expectorant
Otc - Purpose
Purpose Expectorant
Indications & Usage
Uses
Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus.
Warnings
Warnings
Do not exceed recommended dosage
Ask a doctor before use if you have
- a cough that is accompanied by excessive phlegm (mucus)
- a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
- cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persstent headached. A persistent cough may be a sign of a serious condition.
Stop use and ask a doctor if
Otc - Keep Out Of Reach Of Children
Keep Out of Reach of Children.
In case of accidental overdose, get medical help or contact the Poison Control Center right away.Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding,ask a health professional before use.
Dosage & Administration
Directions:
Shake well immediately before use.
Do not exceed 6 doses in any 24 hour period.
Adults and Children 12 years and over - 10 ml (2 tsps) every 4 hours
Children 6 to under 12 years of age - 5 ml (1 tsp) every 4 hours
Children under 6 years of age - Do not use
Inactive Ingredient
Inactive Ingredients:Aloe Vera, Aspartame, Honey, Menthol, Methylparaben, Potassium Sorbate, Propylene Glycol, Propylparaben, Purified Water
Other Safety Information
Each 5 mls contains: sodium 5 mg, and potassium 5 mg
Phenylketonurics: Contains Phenylalanine 2.5 mg per 5 ml (teaspoonful).
Otc - Questions
Questions or Comments?
305.805.3456 Monday-Friday 9AM to 5PM EST
www.efficientlabs.com
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