Guaifenesin and Codeine Phosphate

Guaifenesin and Codeine Phosphate is an FDA-registered drug product whose active ingredient is GUAIFENESIN AND CODEINE PHOSPHATE. It is labelled by Cardinal Health 107, LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 55154-5791, application M012, label effective 20260602. 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 AND CODEINE PHOSPHATE are most often described in connection with: temporarily relieves, cough due, minor throat, bronchial irritations, common cold, inhaled irritants, helps loosen, phlegm mucus. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses • temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive

Directions • take every 4 hours • do not exceed 6 doses in 24 hours • a special measuring device should be used to give an accurate dose of this product to children under 6 years of age • giving a higher dose than recommended by a doctor can result in serious side effects for a child adults and children 12 years and over 10 mL (2 teaspoonfuls) children 6 to under 12 years of age 5 mL (1 teaspoonful) children under 6 years of age Consult a doctor

Warnings Do not use • in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor. Ask a doctor before use if you have • a cough with too much phlegm (mucus) • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone. Stop use and ask a doctor if • cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition. • may cause or aggravate constipation If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. • Use of codeine-containing preparation is not recommended for children under 2 years of age.

3 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 and Codeine Phosphate used for?
Uses • temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive

Who makes Guaifenesin and Codeine Phosphate?
Cardinal Health 107, LLC is the labeler of record for Guaifenesin and Codeine Phosphate.

What form does Guaifenesin and Codeine Phosphate 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 and Codeine Phosphate 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.

Has Guaifenesin and Codeine Phosphate been recalled?
3 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.