Drug Facts
Composition & Profile
Identifiers & Packaging
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.; 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 5 mL unit dose cup label; 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 118 mL bottle label; 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 237 mL bottle label; 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 473 mL bottle label; PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label Delivers 10 mL NDC 0121-1276-10 GUAIFENESIN SYRUP and DEXTROMETHORPHAN 200 mg/20 mg per 10 mL Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT 10 unit dose cup label
- 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.
- 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 5 mL unit dose cup label
- 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 118 mL bottle label
- 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 237 mL bottle label
- 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 473 mL bottle label
- PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label Delivers 10 mL NDC 0121-1276-10 GUAIFENESIN SYRUP and DEXTROMETHORPHAN 200 mg/20 mg per 10 mL Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT 10 unit dose cup label
Overview
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
Indications & Usage
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
Dosage & Administration
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
Warnings & Precautions
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. you are hypersensitive to any of the ingredients. 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.
Purpose
Non-Narcotic, Alcohol Free Expectorant/Cough Suppressant
Do Not Use
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.
Stop Use & Ask a Doctor
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. you are hypersensitive to any of the ingredients.
Keep Out of Reach of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Storage & Handling
STORAGE: Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F) [See USP]. Protect from light.
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