Guaifenesin 200mg

Guaifenesin 200mg is an FDA-registered drug product whose active ingredient is GUAIFENESIN. It is labelled by Health Pharma USA LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 71679-148, application M012, label effective 20260707. It is one of 98 FDA drug label records sharing the active ingredient GUAIFENESIN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing GUAIFENESIN are most often described in connection with: temporary symptomatic, congested chests. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Temporary symptomatic relief from congested chests and cough.

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.

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. 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). When using this product Do not exceed recommended dosage. Do not consume alcohol, benzodiazepines or opioids. Stop use and ask a doctor if cough lasts for more than 7 days please consult your physician or healthcare provider. 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 (1-800-222-1222) right away.

FDA lists 98 drug label records with GUAIFENESIN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Guaifenesin 200mg used for?
Uses Temporary symptomatic relief from congested chests and cough.

Who makes Guaifenesin 200mg?
Health Pharma USA LLC is the labeler of record for Guaifenesin 200mg. 98 FDA label records share the active ingredient GUAIFENESIN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Guaifenesin 200mg come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Guaifenesin 200mg prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing GUAIFENESIN?
Yes. 98 FDA drug label records list GUAIFENESIN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Guaifenesin 200mg been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.