Active Ingredient (In Each Immediate-Release Tablet)
Guaifenesin 200 mg
Guaifenesin
FDA Label NDC 54868-5847
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Guaifenesin (NDC 54868-5847). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each immediate-release tablet), purpose, use(s), ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
NDC 54868-5847-0
Product Packaging (5847)
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.
