The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Otc - Purpose
Active ingredients(in each 5 mL = 1 tsp)PurposeCodeine phosphate, USP 10 mg Cough suppressantGuaifenesin, USP 100 mgExpectorant
- ▪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.
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.
- ▪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
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, LLCLanghorne, PA 190471-888-848-3593Made in USARev. 07/20197300-0016
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