Members Mark Mucus Relief DM GUAIFENESIN AND DEXTROMETHORPHAN HBR SAM'S WEST INC FDA Approved Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive 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
ANDA217340
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each extended-release tablet) Guaifenesin USP 1200 mg Dextromethorphan Hydrobromide USP 60 mg
Inactive Ingredients
Inactive ingredients carbomer homopolymer type B colloidal silicon dioxide FD & C Blue #1 ferric oxide yellow hypromellose magnesium stearate microcrystalline cellulose and sodium starch glycolate.
Strengths
1200 mg 60 mg
Treats Conditions
Uses Helps Loosen Phlegm Mucus And Thin Bronchial Secretions To Rid The Bronchial Passageways Of Bothersome Mucus And Make Coughs More Productive 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 BOX
All Product Codes
UNII
9D2RTI9KYH 495W7451VQ
Packaging

Guaifenesin 1200 mg and Dextromethorphan 60 mg Extended-Release Tablets Carton:

Package Descriptions
  • Guaifenesin 1200 mg and Dextromethorphan 60 mg Extended-Release Tablets Carton:

Overview

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive 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 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive 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 crush, chew, or break extended-release tablet take with a full glass of water this product can be administered without regard for timing of meals adults and children 12 years and older: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours. children under 12 years of age: do not use

Warnings & Precautions
Warnings Do not use for children under 12 years of age 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 persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus) When using this product do not use more than directed Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Purpose

Purposes Expectorant Cough suppressant

Do Not Use

Do not use for children under 12 years of age 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.

When Using

When using this product do not use more than directed

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 persistent headache. These could be signs of a serious illness.

Keep Out of Reach of Children

Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Questions

Questions call 1-888-375-3784 Weekdays (8am - 8pm EST) You may also report side effects to this phone number.


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