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
Purpose
Cough Suppressant
Expectorant
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
Warnings
OTC - DO NOT USE SECTION
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 persistant headache. These could be signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a healthcare professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
10 mg-100 mg/5 mL
| 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 |
| 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 5mLNDC 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 10mLNDC 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