Codeine-Guaifenesin
Codeine Phosphate and Guaifenesin · Solution · Oral
Active ingredient
Active ingredient (in each teaspoonful (5 mL)) Codeine Phosphate USP 10 mg Active ingredient (in each teaspoonful (5 mL)) Guaifenesin USP 100 mg
Purpose
Purpose Antitussive Purpose Expectorant
Uses
Uses temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants your cough to help you sleep helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes cough more productive.
Warnings
Warnings Ask your doctor before use if you have a persistent cough, this may be a sign of a serious condition you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema you have a cough that is accompanied by excessive phlegm (mucus) you have chronic pulmonary disease or shortness of breath giving to a child who is taking other drugs When using this product giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. may cause or aggravate constipation Stop use and ask a doctor if symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition. 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.
Ask a doctor before use
Ask your doctor before use if you have a persistent cough, this may be a sign of a serious condition you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema you have a cough that is accompanied by excessive phlegm (mucus) you have chronic pulmonary disease or shortness of breath giving to a child who is taking other drugs
When using this product
When using this product giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. may cause or aggravate constipation
Stop use and ask a doctor
Stop use and ask a doctor if symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition.
Pregnancy or breast-feeding
If pregnant or breast-feeding ask a health professional before use.
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 right away.
Directions
Directions do not exceed 6 doses in 24 hours. Adults and children 12 years of age and over: 2 tsp (10 mL) every 4 hours, or as directed by a doctor. Children 6 to under 12 years of age: 1 tsp (5 mL) every 4 hours, or as directed by a doctor. Children under 6 years of age: Consult a doctor.
Other information
Other information Store at controlled room temperature 15°-30°C (59°-86°F).
Inactive ingredients
Inactive ingredients Cherry Flavor, Citric Acid, Glycerin,Masking flavor, Propylene glycol, Purified Water, Sodium Citrate, Sodium Benzoate, Sucralose Sorbitol.
Label text from the FDA structured product label by Method Pharmaceuticals, LLC (revised Apr 1, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Codeine Phosphate in 6 products
- Guaifenesin in 6 products
Codeine-Guaifenesin NDC products (6)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-6435 | Codeine Phosphate 10 mg/5mL; Guaifenesin 100 mg/5mL Solution | A-S Medication Solutions | OTC MONOGRAPH DRUG · DEA CV |
| 72162-1669 | Codeine Phosphate 10 mg/5mL; Guaifenesin 100 mg/5mL Solution | Bryant Ranch Prepack | OTC MONOGRAPH DRUG · DEA CV |
| 58657-500 | Codeine Phosphate 10 mg/5mL; Guaifenesin 100 mg/5mL Solution | Method Pharmaceuticals, LLC | OTC MONOGRAPH DRUG · DEA CV |
| 68071-5173 | Codeine Phosphate 10 mg/5mL; Guaifenesin 100 mg/5mL Solution | NuCare Pharmaceuticals,Inc. | OTC MONOGRAPH DRUG · DEA CV |
| 71205-624 | Codeine Phosphate 10 mg/5mL; Guaifenesin 100 mg/5mL Solution | Proficient Rx LP | OTC MONOGRAPH DRUG · DEA CV |
| 69367-272 | Codeine Phosphate 10 mg/5mL; Guaifenesin 100 mg/5mL Solution | Westminster Pharmaceuticals, LLC | OTC MONOGRAPH DRUG · DEA CV |
Codeine-Guaifenesin recalls
- D-0210-2018 Jan 17, 2018 · Class II · Terminated
Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia
Frequently asked questions
What is Codeine-Guaifenesin used for?
Uses temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants your cough to help you sleep helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes cough more productive.
Who makes Codeine-Guaifenesin?
Codeine-Guaifenesin is listed by 6 labelers in the FDA NDC directory, including A-S Medication Solutions, Bryant Ranch Prepack, Method Pharmaceuticals, LLC, NuCare Pharmaceuticals,Inc..
Has Codeine-Guaifenesin been recalled?
The FDA enforcement database lists 1 recall for Codeine-Guaifenesin, most recently D-0210-2018 (class ii): Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia