Guaifenesin and Dextromethorphan hydrobromide GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE ONCOR PHARMACEUTICALS FDA Approved Uses temporarily Relieves - cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants - the intensity of coughing - the impulse to cough to help you get to sleep
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Route
ORAL
Applications
M012

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each 5 mL teaspoonful) Purpose Dextromethorphan Hydrobromide 10 mg...........Cough Suppressant Guaifenesin 100 mg.............................................Expectorant
Inactive Ingredients
Inactive ingredients cherry flavor citric acid FD&C red no. 40 glycerin propylene glycol purified water sodium benzoate sodium citrate sodium saccharin sorbitol solution sucralose.
Strengths
5 ml 10 mg 100 mg
Treats Conditions
Uses Temporarily Relieves Cough Due To Minor Throat And Bronchial Irritation As May Occur With The Common Cold Or Inhaled Irritants The Intensity Of Coughing The Impulse To Cough To Help You Get To Sleep

Identifiers & Packaging

Container Type UNKNOWN
UPC
0383720501164
UNII
9D2RTI9KYH 495W7451VQ
Packaging

Guaifenesin and Dextromethorphan 16oz Guaifenesin and Dextromethorphan 8oz

Package Descriptions
  • Guaifenesin and Dextromethorphan 16oz Guaifenesin and Dextromethorphan 8oz

Overview

Uses temporarily Relieves - cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants - the intensity of coughing - the impulse to cough to help you get to sleep

Indications & Usage

Uses temporarily Relieves - cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants - the intensity of coughing - the impulse to cough to help you get to sleep

Dosage & Administration

Directions do not exceed recommended dosage. adults and children 12 years and over: 2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours or as directed by a doctor children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours or as directed by a doctor children under 6 years of age: consult a physician

Warnings & Precautions
Warnings Do not exceed recommended dosage.
Purpose

Principal Display Panel Oncor Pharmaceuticals NDC 83720-501-16 Guaifenesin and Dextromethorphan hydrobromide USP 100 mg/10 mg Expectorant Cough Suppressant Non Drowsy - Alcohol Free For Ages 12 & Up CHERRY FLAVOR NET WT. 16 fl. oz. (473 ml) NDC 83720-501-08 Guaifenesin and Dextromethorphan hydrobromide USP 100 mg/10 mg Expectorant Cough Suppressant Non Drowsy - Alcohol Free For Ages 12 & Up CHERRY FLAVOR NET WT. 8 OZ. (237 ml) Manufactured In USA For : Oncor Pharmaceuticals 6755 Business Pkwy Suite 202 Elkridge, MD 21075 United States. Rev. 02/25

Do Not Use

Do not use this product 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 occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

Keep Out of Reach of Children

Keep out of reach of children.

Storage & Handling

Other information - store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature] - tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Questions

Questions? You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.


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