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 Physicians Total Care, 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 Immediate-Release Tablet)
Guaifenesin 200 mg
Purpose
Expectorant
Use(S)
Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Ask A Doctor Before Use If You Have
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough accompanied by too much phlegm (mucus)
Stop Use And Ask A Doctor If
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
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 right away.
Directions
- do not exceed 6 doses in 24 hours
- take with a full glass of water
adults and children 12 years of age and over | 1 to 2 tablets every 4 hours |
children 6 to under 12 years of age | ½ to 1 tablet every 4 hours |
children under 6 years of age | consult a physician |
Other Information
- store at controlled room temperature 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive Ingredients
FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silica gel, sodium starch glycolate, stearic acid
Questions?
To Report Adverse Drug Event Call: (800) 616-2471
Principal Display Panel
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
NDC 54868-5847-0
GUAIFENESIN TABLETS
Guaifenesin 200 mg
Expectorant
- Relieves Chest Congestion
- Thins and Loosens Mucus 100 Tablets Immediate Release
50844 REV0510A58812
Distributed by MAJOR PHARMACEUTICALS
31788 Enterprise Drive,
Livonia, MI 48150 USA
Re-Order No. 238163 M-17 Rev. 11/10
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
* Please review the disclaimer below.