The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Guaifenesin And Dextromethorphan (NDC 0904-7512). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each 5 ml cup) purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Guaifenesin 100 mg .............................................................................................................................. Expectorant
Dextromethorphan hydrobromide 10 mg ............................................................................................ Cough Suppressant
• 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 a cold.
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.
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
ask a health professional before use
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)
Follow dosage below or use as directed by a physician.
do not take more than 6 doses in any 24-hour period.
single use cup. Dose only with cup provided.
each cup delivers 5 mL
mL = Milliliter
| Age (yr) | Dose (mL) |
|---|---|
| adults and children 12 years and over | 10 mL every 4 hours |
| children 6 years to under 12 years | 5 mL every 4 hours |
| children under 6 years of age | ask a doctor |
Each 5 mL contains: sodium 4 mg.
Store at 20° to 25°C (68° to 77°F). Protect from light.
anhydrous citric acid, FD&C Red No. 40, flavor, glycerin, menthol, purified water, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sucrose.
Call1-800-845-8210
Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
R10/24
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
Delivers 5 mL
NDC 0904-7512-41
GUAIFENESIN and DEXTROMETHORPHAN
Syrup
100 mg/10 mg per 5 mL
See Insert for Drug Facts
For Institutional Use Only
Guaifenesin And Dm Syrup-lid (Guaifenesin Dm Guaifenesin And Dextromethorphan S 1)
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