FDA Label for Codeine-guaifenesin
View Indications, Usage & Precautions
Codeine-guaifenesin Product Label
The following document was submitted to the FDA by the labeler of this product Westminster Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Otc - Purpose
| Active ingredients (in each 5 mL = 1 tsp) | Purpose |
|---|---|
| Codeine phosphate, USP 10 mg | Antitussive |
| Guaifenesin, USP 100 mg | Expectorant |
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.
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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 Anhydrous, Glycerin, Masking Agent, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sorbitol Solution, Sucralose.
Principal Display Panel - 118 Ml Bottle Label
NDC 69367-272-04
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)
4 fl. oz. (118 mL)
Westminster
Pharmaceuticals
* Please review the disclaimer below.