Otc - Active Ingredient
Active ingredient (in each caplet)
Guaifenesin 400 mg
Guaifenesin Tablet
FDA Label NDC 71679-309
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Health Pharma Usa Llc for the product Guaifenesin (NDC 71679-309). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Expectorant
Indications & Usage
Uses
- Temporary symptomatic relief from congested chests and cough.
Warnings
Warnings
A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.
Otc - Ask Doctor
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 excessive phlegm (mucus).
Otc - When Using
When using this product
- Do not exceed recommended dosage.
- Do not consume alcohol, benzodiazepines or opioids.
Otc - Stop Use
Stop use and ask a doctor if
cough lasts for more than 7 days please consult your physician or healthcare provider.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding,ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Dosage & Administration
Directions
- Adults and children 12 years of age and over:take 1 caplet a day.
- Children under 12 years:Do not use.
- Do not exceed 4 doses in 24 hours.
Other Safety Information
Other information
■ Store at 25°C (77°F) excursions between 15°-30°C (59°-86°F).
■ Keep in a dry place and do not expose to heat.
■ Read all product information before use.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive Ingredient
Inactive ingredients
Croscarmellose sodium, Maltodextrin, PVP K30, Silicon dioxide, Microcrystalline cellulose, stearic acid, Purified water.
Otc - Questions
Questions or comments?
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