• 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 cough 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.
Each tsp (5 mL) contains 4 mg sodium. Store at controlled room temperature 15° to 30°C (59° to 86° F). You may report side effects by calling Virtus Pharmaceuticals, LLC at 1-888-848-3593 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 |
Ask your doctor before use if
When using this product
Stop use and ask a doctor if
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. |
Each tsp (5 mL) contains 4 mg sodium.
Store at controlled room temperature 15° to 30°C (59° to 86° F). You may report side effects by calling Virtus Pharmaceuticals, LLC at 1-888-848-3593 or FDA at 1-800-FDA-1088
Alcohol, caramel flavor, cherry flavor, citric acid, FD&C Red #40, glycerin, menthol flavor, purified water, sodium benzoate, sodium saccharin, sorbitol.
Manufactured for:
Virtus Pharmaceuticals, LLC
Newtown, PA 18940
Made in USA
Rev. 07/2017
7300-0016
VIRTUS®
PHARMACEUTICALS
NDC: 69543-276-16
Codeine phosphate and
Guaifenesin oral solution
10 mg/100 mg Per 5 mL
Antitussive
Expectorant
CV
SUGAR FREE
Each 5 mL (1 teaspoonful) contains:
Codeine Phosphate, USP 10 mg
Guaifenesin, USP 100 mg
(WARNING: May be habit-forming)
Alcohol 3.8%
Tamper evident by foil
seal under cap.
Do not use if foil seal is
broken or missing
16 fl. oz. (473 mL)
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69543-276-16 | ML - Milliliter | 69543-276 | 1f7ddbe6-6312-4696-bffe-9af92d2d3bea | 1 | 2017-12-14 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69543-276 | 69543-276-16 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Codeine Phosphate | GSL05Y1MN6 | ACTIB |
| Guaifenesin | 495W7451VQ | ACTIB |
| ALCOHOL | 3K9958V90M | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| SORBITOL | 506T60A25R | IACT |
| FD&C Red NO. 40 | WZB9127XOA | IACT |
| glycerin | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | 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 |
|---|---|---|---|---|---|---|
| 7395e69a-5cf3-402d-a46b-08e2df1708a2 | 207fbcc1-ce05-423c-8b50-3b07dc3b59a9 | 2020-06-09 | Warnings | 7395e69a-5cf3-402d-a46b-08e2df1708a2 207fbcc1-ce05-423c-8b50-3b07dc3b59a9 |
Adverse event summaries are temporarily unavailable. Other product information remains available.