Active Ingredient (In Each Immediate-Release Tablet)
Guaifenesin 200 mg
Guaifenesin Tablet
FDA Label NDC 0904-5154
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Guaifenesin (NDC 0904-5154). 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, uses, 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
Uses
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 |
| children under 6 years of age | consult a physician |
Other Information
- store at 25°C (77°F); excursions permitted between 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 Or Comments?
(800) 616-2471
Principal Display Panel
NDC 0904-5154-60
MAJOR®
GUAIFENESIN
TABLETS
Guaifenesin 200 mg
Expectorant
- Relieves Chest Congestion
- Thins and Loosens Mucus
100Tablets
Immediate Release
50844 REV0812B58812
Distributed by MAJOR® PHARMACEUTICALS
31778 Enterprise Drive, Livonia, MI 48150 USA
Re-Order No. 238163 M-17 Rev. 04/13
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Major 44-588 (Major 44 588 1)
* Please review the disclaimer below.
