Active Ingredient (In Each Tablet)
Guaifenesin 400 mg
Guaifenesin Tablet
FDA Label NDC 81993-002
14 label sections · Submitted to the FDA by Zennova Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zennova Llc for the product Guaifenesin (NDC 81993-002). 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 tablet), purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, when using this product, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Expectorant
Uses
Temporary symptomatic relief from congested chests and cough.
Warnings
A persistent cough maybe 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.
Do not use - For children under 12 years of age
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
if cough lasts more than 7 days, please consult your physician or healthcare provider.
When Using This Product
- Do not exceed recommended dosage.
- Do not consume alcohol, benzodiazepines or opioids.
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.
If Pregnant Or Breast-Feeding
ask a health professional before use
Directions:
- Adults and children 12 years of age and over: take 1 tablet a day.
- children under 12 years: do not use.
- Do not exceed 4 doses in 24 hours.
Questions Or Comments
Call toll free 1-888-572-7085, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
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 Ingredients
Maltodextrin, Povidone K30, Colloidal Silicon Dioxide, Silicon Dioxide, Stearic Acid
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