DESCRIPTION
| Each 5 mL (1 teaspoonful) contains: | |
| Guaifenesin | 100 mg |
| Dextromethorphan Hydrobromide | 10 mg |
USES
- 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
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
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).
DIRECTIONS: Follow dosage below or use as directed by a physician.
- do not take more than 6 doses in any 24-hour period.
| age | dose |
|---|---|
| adults and children
12 years and over | 10 mL (2 teaspoonfuls)
every 4 hours |
| children 6 years to
under 12 years | 5 mL (1 teaspoonful)
every 4 hours |
| children 2 years to
under 6 years | 2.5 mL (1/2 teaspoonful)
every 4 hours |
| children under 2 years | ask a doctor |
HOW SUPPLIED: Guaifenesin Syrup and Dextromethorphan is a red, cherry flavored syrup supplied in the following oral dosage forms:
NDC 0121-0638-04: 4 fl oz (118 mL) bottle
NDC 0121-0638-08: 8 fl oz (237 mL) bottle
NDC 0121-0638-16: 16 fl oz (473 mL) bottle
NDC 01210638-05: 5 mL unit dose cup
NDC 0121-0638-00: Case contains 100 unit dose cups of 5 mL (0121-0638-05) packaged in 10 trays of 10 unit dose cups each.
NDC 0121-1276-10: 10 mL unit dose cup
NDC 0121-1276-00: Case contains 100 unit dose cups of 10 mL (0121-1276-10) packaged in 10 trays of 10 unit dose cups each.
STORAGE: Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F) [See USP]. Protect from light.
PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label
Delivers 5 mL
NDC 0121-0638-05
GUAIFENESIN SYRUP
and DEXTROMETHORPHAN
100 mg/10 mg per 5 mL
Package Not Child-Resistant
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
NDC 0121-0638-04
NSN 6505-01-318-1565
Quality®
Value
Guaifenesin-DM
100 mg/10 mg per 5 mL
EXPECTORANT/COUGH SUPPRESSANT
Compare to the
active ingredients in
*Robitussin
®-DM
CONTROLS COUGHS
LOOSENS AND RELIEVES
CHEST CONGESTION
4 fl oz (118 mL)
Pharmaceutical
Associates, Inc.
Greenville, SC 29605
PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
NDC 0121-0638-08
Quality®
Value
Guaifenesin-DM
100 mg/10 mg per 5 mL
EXPECTORANT/COUGH SUPPRESSANT
Compare to the
active ingredients in
*Robitussin
®-DM
CONTROLS COUGHS
LOOSENS AND RELIEVES
CHEST CONGESTION
8 fl oz (237 mL)
Pharmaceutical
Associates, Inc.
Greenville, SC 29605
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
NDC 0121-0638-16
Quality®
Value
Guaifenesin-DM
100 mg/10 mg per 5 mL
EXPECTORANT/COUGH SUPPRESSANT
Compare to the
active ingredients in
*Robitussin
®-DM
CONTROLS COUGHS
LOOSENS AND RELIEVES
CHEST CONGESTION
16 fl oz (473 mL)
Pharmaceutical
Associates, Inc.
Greenville, SC 29605
