Active Ingredient (In Each Immediate-Release Tablet)
Guaifenesin 200 mg
Guaifenesin
FDA Label NDC 49349-511
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Remedyrepack Inc. for the product Guaifenesin (NDC 49349-511). 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
Package Label.Principal Display Panel
DRUG: Guaifenesin
GENERIC: Guaifenesin
DOSAGE: TABLET
ADMINSTRATION: ORAL
NDC: 49349-511-02
COLOR: pink
SHAPE: ROUND
SCORE: No score
SIZE: 10 mm
IMPRINT: 44;588
PACKAGING: 30 in 1 BLISTER PACK
ACTIVE INGREDIENT(S):
- GUAIFENESIN 200mg in 1
- FD&C RED NO. 40
- MAGNESIUM STEARATE
- STEARIC ACID
- POVIDONE
- CELLULOSE, MICROCRYSTALLINE
- MALTODEXTRIN
- SILICON DIOXIDE
INACTIVE INGREDIENT(S):
Remedy_label (Remedy Label)
* Please review the disclaimer below.
