ROBAFEN AC- guaifenesin and codeine phosphate syrup
Major Pharmaceuticals
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
----------
Each teaspoonful (5 mL) contains:
Guaifenesin USP 100 mg
Codeine Phosphate USP 10 mg
Contains 3.5% alcohol v/v
Indications:
Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants.
Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants.
Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Warnings:
Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless dirrected by a doctor. A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor. Adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, should not take this product unless directed by a doctor. May cause or aggravate constipation. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. Keep this and all drugs out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
UNDER FEDERAL LAW ROBAFEN AC IS AVAILABLE WITHOUT A PRESCRIPTION. CERTAIN STATE LAWS MAY DIFFER.
Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directled by a doctor.
If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
Drug Interaction Precaustion:
Caution should be used when taking this product with sedatives, tranquilizers and drugs used for depression, especially monoamine oxidate inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone.
Stop use and ask a doctor if cough persists for more than 1 week, tends to recur or is accompanied by fever, rash or presistent headache. Adults and children who have a chronic pulmonary disease or shortness of breath or children who are taking other drugs, should not take this product unless by a doctor,
As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.
Keep this and all drugs out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Directions:
Take every 4 hours or as directed by a doctor. Do not exceed 6 doses in 24 hours.
Adults and children 12 years of age and over: Take 2 teaspoonfuls.
Children 6 to under 12 years of age: Give 1 teaspoonful.
Not intended for children under 6 years of age. Giving a higher dose than recommended by a doctor
could result n serious side effects for your child. Do not exceed recommended dosage.
Drug Interaction Precaution: Caution should be used when taking this product with sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone.Dispense in a tight, light-resistant container as defined in the USP. Store at controlled room temperature 20 to 25 degrees C (68 to 77 degrees F). Do not refrigerate.
ROBAFEN AC
guaifenesin and codeine phosphate syrup |
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
Labeler - Major Pharmaceuticals (191427277) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Major Pharmaceuticals | 191427277 | REPACK(0904-5065) |