(dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride)
[Gil Pharmaceutical Corp]
|Category||DEA Schedule||Marketing Status|
|HUMAN OTC DRUG LABEL||OTC monograph final|
(in each 5 mL teaspoonful)
Dextromethorphan HBr, 28 mg
Guaifenesin, 388 mg
Phenylephrine HCl, 10 mg
- 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 cough more productive
- temporarily relieves nasal congestion due to a cold
Do not use if
you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate 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
Ask a doctor or pharmacist before use if you are
taking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs).
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- 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.
- do not exceed recommended dosage
- take every 6-8 hours
|adults and children 12 years & over||5 mL (1 teaspoonful)|
|children 6 to under 12 years of age||2.5 mL (1/2 teaspoon)|
|children 2 to 6 years of age||1.25 mL (1/4 teaspoon)|
|children under 2 years of age||Consult a doctor|
- Tamper evident: Do not use if safety seal is broken or missing
- Store at controlled room temperature, between 15°-30°C (59°-86°F)
Artificial grape and vanilla flavor, bitter mask, citric acid, grapeskin extract, menthol, monoammonium glycyrrhizinate, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose. Sodium citrate may be used to adjust pH.
Questions or Comments?
Call 1-877-746-9114, Mon.-Fri. 8:00 am thru 5:00 pm EST. Call your doctor for medical advice in the event of side effects.
Rev. 324:01 6/10
Package/Label Principal Display Panel
NEW IMPROVED FORMULA
Each 5 mL (one teaspoonful) contains:
Dextromethorphan HBr............................28 mg
Phenylephrine HCl..................................10 mg
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup
|Labeler - Gil Pharmaceutical Corp (176826592)|
|Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)|
|Hi-Tech Pharmacal Co., Inc.||101196749||MANUFACTURE|