Indications and 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
• 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
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
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.
• 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 persistant headache. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a healthcare professional before use.
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
Case Label NDC 57237-312-51
20 mg-200 mg/10 mL
Lid Label NDC 57237-313-01
Case Label NDC 57237-313-18
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | Code 128 | 5723731205 | Guai-Dextro-lid-label-5ml.jpg | |
| Data code | Code 128 | 5723731301 | Guai-Dextro-lid-label-10ml.jpg |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57237-312-05 | ML - Milliliter | 57237-312 | b4445953-07cc-4aef-bec3-b0d9427f6798 | 1 | 2023-07-06 |
| 57237-312-51 | ML - Milliliter | 57237-312 | 474f4a31-90f7-44ca-8151-f945ba6b7987 | 1 | 2023-07-06 |
| 57237-313-01 | ML - Milliliter | 57237-313 | b4b7f776-ef79-4ae7-91fd-645b4e7d702c | 1 | 2023-07-06 |
| 57237-313-18 | ML - Milliliter | 57237-313 | 1a032e32-c5d7-44b4-8e28-95a98c950ff8 | 1 | 2023-07-06 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 57237-312 | 57237-312-05, 57237-312-51 |
| 57237-313 | 57237-313-01, 57237-313-18 |
Every source-derived ingredient row is available through these pages.
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2025-07-01 | full-release | 2026-06-01 01:06:42 |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 914d13bb-fbd6-420f-ad2c-1df3828d18c3 | e463e60f-d0db-4ee7-9713-ddf25aa38a43 | 2025-07-01 | Warnings | e463e60f-d0db-4ee7-9713-ddf25aa38a43 |
Adverse event summaries are temporarily unavailable. Other product information remains available.