Medically reviewed on November 13, 2017.
Dosage form: liquid
Ingredients: CODEINE PHOSPHATE 10mg in 5mL, GUAIFENESIN 100mg in 5mL
Labeler: Hi-Tech Pharmacal Co., Inc.
NDC Code: 50383-087
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.
Codeine Phosphate, USP 10 mg
Guaifenesin, USP 100 mg
- 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
- 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.
- a cough with too much phlegm (mucus)
- a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
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.
- 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
ask a health professional before use.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
- Use of codeine-containing preparation is not recommended for children under 2 years of age
- 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.
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
- 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)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.
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- Drug class: upper respiratory combinations