FDA Label for Guaifenesin
View Indications, Usage & Precautions
Guaifenesin Product Label
The following document was submitted to the FDA by the labeler of this product Innovida Pharmaeutique Corporation. 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.
Active Ingredient ( In Each Tablet)
Guaifenesin 400mg
Purpose
Expectorant
Uses
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
• helps make coughs more productive
Warnings
Ask doctor before use ifyou have
• persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysema
• cough is accompanied by excessive phlegm (mucus)
Stop use and ask doctor if
• Symptoms are accompanied by fever, rash or persistent headache
• cough persists for more than 1 week or tends to recur
A persistent cough may be a sign of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
Directions
•
Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed
•
Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed
•
Children under 6 years of age: consult a doctor
Do not exceed 6 doses in a 24 hour period or as directed by a doctor
Inactive Ingredients
magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid.
Other Information
store at 15°-30°C (59°-86°F)
Product Label
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