Dextromethorphan HBr. and Guaifenesin DEXTROMETHORPHAN HBR. AND GUAIFENESIN RISING PHARMA HOLDINGS, INC. FDA Approved 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

Drug Facts

Composition & Profile

Active Ingredients
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
Inactive Ingredients
Inactive Ingredients citric acid FD&C red#40 flavor menthol methylparaben propylene glycol propylparaben purified water sodium citrate and sucralose.
Strengths
5 ml 100 mg 10 mg 05 unit 10 ml 200 mg 20 mg 01 unit 100 mg/5 ml 1 unit 200 mg/10 ml
Quantities
5 ml 10 ml
Treats Conditions
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
Pill Appearance
Color: red

Identifiers & Packaging

Container Type UNKNOWN
UNII
495W7451VQ 9D2RTI9KYH
Packaging

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; 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 Guai-Dextro-lid-label-5ml Guai-Dextro-case-label-5ml Guai-Dextro-lid-label-10ml Guai-Dextro-case-label-10ml

Package Descriptions
  • 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
  • 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 Guai-Dextro-lid-label-5ml Guai-Dextro-case-label-5ml Guai-Dextro-lid-label-10ml Guai-Dextro-case-label-10ml

Overview

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

Indications & Usage

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 & 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

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 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)
Purpose

Purpose Cough Suppressant Expectorant

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 persistant headache. These could be signs of a serious condition.

Keep Out of Reach of Children

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)

Questions

Questions or comments? Call 1-844-474-7464 Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Issued: 04/2023


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