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 Ohm 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.
Active Ingredient
(in each extended-release tablet)
Guaifenesin, USP
Purpose
Expectorant
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Uses
• Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bronchial mucus and make coughs more productive
Warnings
Do not use
• for children under 12 years of age• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema• cough accompanied by too much phlegm (mucus)• cough lasts more than 7 days, comes back or occurs with fever, rash, or persistent headache.
Ask a doctor before use if you have
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Directions
• do not crush, chew or break extended-release tablet• take with a full glass of water• this product can be administered without regard for the timing of meals• adults and children over 12 years of age and over: one or two extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours.• children under 12 years of age: do not use.• store between 20-25°C (68-77°F)• TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SEAL ON BLISTER IS BROKEN OR MISSING.
Other information
Keep the carton. It contains important information. See end panel for expiration date.
†Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.
Inactive Ingredients
colloidal silicon dioxide, FD&C blue # 2, aluminum lake, hypromellose, magnesium stearate, povidone.
Questions
call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.
* Please review the disclaimer below.