GUAIFENESIN DM- guaifenesin and dextromethorphan solution
Pharmaceutical Associates, Inc.
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.
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Maximum Strength
Guaifenesin DM
Non-Narcotic, Sugar and Alcohol Free
Expectorant/Cough Suppressant
Uses
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Warnings
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
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Stop use and ask a doctor if 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.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- shake well before using
- do not take more than 6 doses in any 24-hour period
age dose adults and children 12 years and over 10 mL (2 teaspoonsful) every 4 hours children 6 to under 12 years of age 5 mL (1 teaspoonful) every 4 hours children 2 to under 6 years of age 2.5 mL (1/2 teaspoonful) every 4 hours children under 2 years consult a doctor
Other information
- each teaspoonful contains: sodium 4 mg
- store at 20° - 25°C (68° - 77°F)
- alcohol/sugar free
- red, cherry flavored solution supplied in the following oral dosage forms: NDC 0121-0809-04 (4 fl oz bottle), NDC 0121-0809-08 (8 fl oz bottle), NDC 0121-4809-05 (unit dose cups of 5 mL, packaged in trays of 10), and NDC 0121-4809-10 (unit dose cups of 10 mL, packaged in trays of 10).
Inactive ingredients
Acesulfame K, citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol and sucralose.
Questions or comments?
Call 1-800-845-8210. You may also report serious side effects to this phone number.
PRINCIPAL DISPLAY PANEL - 118 mL Label
NDC 0121-0809-04
Quality®
Value
Maximum Strength
Guaifenesin DM
Cough & Chest
Congestion
DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)
ALCOHOL / SUGAR FREE
Relieves Cough /
Maximum Strength
Mucus Relief
4 fl oz (118 mL)
PRINCIPAL DISPLAY PANEL - 5 mL Lid
Delivers 5 mL
NDC 0121-4809-05
MAXIMUM STRENGTH
GUAIFENESIN DM
Guaifenesin (Expectorant)
Dextromethorphan HBr (Cough Suppressant)
200 mg/10 mg per 5 mL
Alcohol Free / Sugar Free
FOR INSTITUTIONAL USE ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
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guaifenesin and dextromethorphan solution |
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| Labeler - Pharmaceutical Associates, Inc. (044940096) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Pharmaceutical Associates, Inc. | 044940096 | MANUFACTURE | |