Codeine-guaifenesin
3da3efd7-e278-4d79-9130-eef3992097e4
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Medication Information
Description
Drug Facts
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 make coughs more productive.
Section 42229-5
Drug Facts
Section 50565-1
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1
| Active ingredients (in each 5 mL = 1 tsp) | Purpose |
|---|---|
| Codeine phosphate, USP 10 mg | Antitussive |
| Guaifenesin, USP 100 mg | Expectorant |
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
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.
Inactive Ingredients
Cherry flavor, citric acid, methylparaben, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, sorbitol, sucralose.
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.
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
Principal Display Panel 473 Ml Bottle Label
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
Structured Label Content
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 make coughs more productive.
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1 (55105-1)
| Active ingredients (in each 5 mL = 1 tsp) | Purpose |
|---|---|
| Codeine phosphate, USP 10 mg | Antitussive |
| Guaifenesin, USP 100 mg | Expectorant |
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).
You may report side effects by calling 1-844-221-7294 or FDA at 1-800-FDA-1088.
Inactive Ingredients
Cherry flavor, citric acid, methylparaben, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, sorbitol, sucralose.
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 If (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.
Ask Your Doctor Before Use If (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
Principal Display Panel 473 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label)
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
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:06:07.468910 · Updated: 2026-03-14T23:08:44.584027