(guaifenesin and codeine phosphate)
[Hi-Tech Pharmacal Co., Inc.]
|Category||DEA Schedule||Marketing Status|
|HUMAN OTC DRUG LABEL||CV||OTC monograph final|
- temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants
- helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
Do not use
- in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor.
Ask a doctor before use if you have
- a cough with too much phlegm (mucus)
- a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor or pharmacist before use if you are
taking 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.
Stop use and ask a doctor if
- cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition.
- may cause or aggravate constipation
- take every 4 hours
- do not exceed 6 doses in 24 hours
- a special measuring device should be used to give an accurate dose of this product to children under 6 years of age
- giving a higher dose than recommended by a doctor can result in serious side effects for a child
|adults and children 12 years and over||2 teaspoonfuls|
|children 6 to under 12 years of age||1 teaspoonful|
|children under 6 years of age||Consult a doctor|
- each (5 mL) teaspoon contains: 1 mg sodium
- Tamper evident: Do not use if seal under cap is broken or missing
- Keep container closed and store away from heat
- Store at room temperature 15°-30°C (59°-86°F)
alcohol 3.5% v/v, artificial cherry flavor, caramel, citric acid, FD&C red # 40, glycerin, polyethylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution.
Questions or comments?
Call 1-800-262-9010, Mon. - Thurs. 9:00 am thru 4:30 pm EST, Fri. 9:00 am thru 2:30 pm EST.
Serious side effects associated with use of this product may be reported to this number.
REV. 087:01 9/11
Package/Label Principal Display Panel
- Cough Suppressant
Each teaspoonful (5 mL) contains
Codeine Phosphate..................10 mg
Alcohol.......................................3.5 % v/v
Hi-Tech Pharmacal Co., Inc.
Amityville, NY 11701
16 fl oz (473 mL)
guaifenesin and codeine phosphate liquid
|Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)|
|Hi-Tech Pharmacal Co., Inc.||101196749||MANUFACTURE(50383-087)|