FDA Label for Guaifenesin
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
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Guaifenesin Product Label
The following document was submitted to the FDA by the labeler of this product Rite Aid. 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 immediate-release tablet)
Guaifenesin 400 mg
Otc - Purpose
Purpose
Expectorant
Indications & Usage
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus
Warnings
Warnings
Otc - Ask Doctor
Ask a doctor before use if you have
- persistant or chronic cough such as occurs with smoking , asthma, chronic bronchitis, or emphysema
- cough accompanied by excessive phlegm (mucus)
Otc - When Using
When using this product
- do not exceed recommended dosage
- do not use for more than 7 days
Otc - Stop Use
Stop use and ask a doctor if
- cough lasts for more than 7 days, recurs, 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 healthcare 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 (1-800-222-1222) right away.
Dosage & Administration
Directions
- adults and children 12 years of age and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
- children under 12 years of age: do not use
Other Safety Information
Other information
- store at 25°C (77°F) excursions permitted between 15°-30°C (59°- 86°F)
- keep in a dry place and do not expose to excessive heat
Inactive Ingredient
Inactive ingredients colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid
Otc - Questions
Questions or comments? Call 1-877-290-4008
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