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 make coughs more productive.
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.
Store at controlled room temperature 15°-30°C (59°-86°F). You may report side effects by calling 1-844-221-7294 or FDA at 1-800-FDA-1088.
Drug Facts
| Active ingredients (in each 5 mL = 1 tsp) | Purpose |
|---|---|
| Codeine phosphate, USP 10 mg | Antitussive |
| Guaifenesin, USP 100 mg | Expectorant |
If pregnant or breast-feeding, ask a health professional before use.
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
| 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. |
Store at controlled room temperature 15°-30°C (59°-86°F).
You may report side effects by calling 1-844-221-7294 or FDA at 1-800-FDA-1088.
Cherry flavor, citric acid, methylparaben, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, sorbitol, sucralose.
NDC 69367-272-16
Codeine-
Guaifenesin
Oral Solution
10-100 mg/5 mL
Antitussive/Expectorant
Sugar Free, Alcohol Free, Dye Free
Each 5 mL (1 teaspoonful) contains:
Codeine phosphate, USP
10 mg
Guaifenesin, USP
100 mg
(WARNING: May be habit-forming)
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.
16 fl. oz. (473 mL)
Westminster
Pharmaceuticals
| Class | Version | Type | Effective |
|---|---|---|---|
| CODEINE ANHYDROUS Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69367-272-04 | Codeine-Guaifenesin | 118 mL in 1 BOTTLE | SOLUTION | 118 | 6 | |
| 69367-272-16 | Codeine-Guaifenesin | 473 mL in 1 BOTTLE | SOLUTION | 473 | 6 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69367-272 | 69367-272-04, 69367-272-16 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CODEINE PHOSPHATE | GSL05Y1MN6 | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| POTASSIUM CITRATE | EE90ONI6FF | IACT |
| POTASSIUM SORBATE | 1VPU26JZZ4 | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Codeine-Guaifenesin | CODEINE PHOSPHATE AND GUAIFENESIN | Westminster Pharmaceuticals, LLC | 3da3efd7-e278-4d79-9130-eef3992097e4 | 2025-05-08 | Warnings | 69367-272-16 69367-272-04 69367-272 69367027216 69367027204 82e575e8-9a6e-432e-8991-8f640de01dd6 3da3efd7-e278-4d79-9130-eef3992097e4 |