Dextromethorphan HBr. and Guaifenesin

10 mg-100 mg/5 mL -

Active ingredient per 5 mL (1 unit dose) 

Dextromethorphan HBr. 10 mg

Guaifenesin 100 mg

20 mg-200 mg/10 mL -

Active ingredient per 10 mL (1 unit dose)    

Dextromethorphan HBr. 20 mg

Guaifenesin 200 mg

Cough Suppressant

Expectorant

•   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

Label information

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

Label information

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs of a serious condition.

Label information

If pregnant or breast-feeding, ask a healthcare professional before use.

Label information

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

•   do not take more than 6 doses in any 24 hour period

20 mg-200 mg/10 mL

age	dose
Children under 12 years of age	Do not use
Adults and children over 12 years of age	10 mL (1 unit dose) every 4 hours

10 mg-100 mg/5 mL

age	dose
Children under 6 years of age	Do not use
Children 6 to under 12 years of age	5 mL (1 unit dose) every 4 hours
Adults and children over 12 years of age	10 mL (2 unit dose) every 4 hours

Other Information
•   store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

•   do not use if lid is torn or broken

Inactive Ingredients citric acid, FD&C red#40, flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose.

NDC Information -

Each 5 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 100mg and Dextromethorphan Hydrobromide 10mg and is supplied in the following oral dosage forms:

NDC 57237-312-05  unit dose cup 5mL
NDC 57237-312-51 (100 x 5 mL) unit-dose cups

Each 10 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 200mg and Dextromethorphan Hydrobromide 20mg and is supplied in the following oral dosage forms:

NDC 57237-313-01 unit dose cup 10mL
NDC 57237-313-18 (80 x 10 mL) unit-dose cups

Questions or comments? Call 1-844-474-7464

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Issued: 04/2023

10 mg-100 mg/5 mL

Lid Label       NDC 57237-312-05

[Image in the official label — see DailyMed source]

Case Label    NDC 57237-312-51

[Image in the official label — see DailyMed source]

20 mg-200 mg/10 mL

Lid Label       NDC  57237-313-01

[Image in the official label — see DailyMed source]

Case Label    NDC  57237-313-18

[Image in the official label — see DailyMed source]