Guaifenesin and Codeine Phosphate
Solution · Oral
Active ingredient
Active ingredients in each 5 mL (teaspoonful) Purposes Codeine Phosphate, USP 10 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant
Purpose
Active ingredients in each 5 mL (teaspoonful) Purposes Codeine Phosphate, USP 10 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant
Uses
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
Warnings
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.
Do not use
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
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
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
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
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 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.
Directions
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
Other information
Other information Sodium Content: 5 mg/5 mL Tamper evident: Do not use if seal under cap is broken or missing Keep container closed and store away from heat Store at 20°- 25°C (68°-77°F)
Inactive ingredients
Inactive ingredients Citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin and sorbitol.
Questions?
Questions or comments? Call 1-800-845-8210 or visit paipharma.com Serious side effects associated with use of this product may be reported to this number.
Label text from the FDA structured product label by PAI Holdings, LLC (revised Sep 6, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Guaifenesin in 6 products
- Codeine Phosphate in 6 products
Guaifenesin and Codeine Phosphate NDC products (6)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-1428 | Guaifenesin 100 mg/5mL; Codeine Phosphate 10 mg/5mL Solution | A-S Medication Solutions | OTC MONOGRAPH DRUG · DEA CV |
| 55154-5791 | Codeine Phosphate 10 mg/5mL; Guaifenesin 100 mg/5mL Solution | Cardinal Health 107, LLC | OTC MONOGRAPH DRUG · DEA CV |
| 0121-0775 | Guaifenesin 100 mg/5mL; Codeine Phosphate 10 mg/5mL Solution | PAI Holdings, LLC | OTC MONOGRAPH DRUG · DEA CV |
| 0121-1550 | Guaifenesin 200 mg/10mL; Codeine Phosphate 20 mg/10mL Solution | PAI Holdings, LLC | OTC MONOGRAPH DRUG · DEA CV |
| 0121-1775 | Guaifenesin 100 mg/5mL; Codeine Phosphate 10 mg/5mL Solution | PAI Holdings, LLC | OTC MONOGRAPH DRUG · DEA CV |
| 68788-8361 | Guaifenesin 100 mg/5mL; Codeine Phosphate 10 mg/5mL Solution | Preferred Pharmaceuticals Inc. | OTC MONOGRAPH DRUG · DEA CV |
Guaifenesin and Codeine Phosphate recalls
- D-0222-2025 Feb 12, 2025 · Class III · Terminated
Superpotent; sodium benzoate preservative
Frequently asked questions
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?
Guaifenesin and Codeine Phosphate is listed by 4 labelers in the FDA NDC directory, including A-S Medication Solutions, Cardinal Health 107, LLC, PAI Holdings, LLC, Preferred Pharmaceuticals Inc..
Has Guaifenesin and Codeine Phosphate been recalled?
The FDA enforcement database lists 1 recall for Guaifenesin and Codeine Phosphate, most recently D-0222-2025 (class iii): Superpotent; sodium benzoate preservative