e463e60f-d0db-4ee7-9713-ddf25aa38a43
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
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
Purpose
Cough Suppressant Expectorant
Medication Information
Purpose
Cough Suppressant
Expectorant
Dosage and Administration
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 |
Dosage Forms and Strengths
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
Description
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
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
Section 50565-1
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)
Section 50566-9
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.
Section 50570-1
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.
Section 51727-6
Inactive Ingredients citric acid, FD&C red#40, flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose.
Section 53413-1
Questions or comments? Call 1-844-474-7464
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Issued: 04/2023
Section 53414-9
If pregnant or breast-feeding, ask a healthcare professional before use.
Section 60561-8
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
Drug Facts
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
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
Package Label.principal Display Panel
10 mg-100 mg/5 mL
Lid Label NDC 57237-312-05
Case Label NDC 57237-312-51
20 mg-200 mg/10 mL
Lid Label NDC 57237-313-01
Case Label NDC 57237-313-18
Structured Label Content
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
Dosage and Administration (34068-7)
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 |
Dosage Forms and Strengths (34069-5)
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
Section 50565-1 (50565-1)
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)
Section 50566-9 (50566-9)
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.
Section 50570-1 (50570-1)
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.
Section 51727-6 (51727-6)
Inactive Ingredients citric acid, FD&C red#40, flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose.
Section 53413-1 (53413-1)
Questions or comments? Call 1-844-474-7464
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Issued: 04/2023
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a healthcare professional before use.
Section 60561-8 (60561-8)
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
Purpose
Cough Suppressant
Expectorant
Drug Facts (DRUG FACTS)
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
Ask A Doctor Before Use If You Have (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
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)
10 mg-100 mg/5 mL
Lid Label NDC 57237-312-05
Case Label NDC 57237-312-51
20 mg-200 mg/10 mL
Lid Label NDC 57237-313-01
Case Label NDC 57237-313-18
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:28.408048 · Updated: 2026-03-14T23:09:15.187219