Guaifenesin and Dextromethorphan HBr GUAIFENESIN AND DEXTROMETHORPHAN HBR OHM LABORATORIES 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
FunFoxMeds box
Route
ORAL
Applications
ANDA214781

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each extended-release tablet) Purposes Dextromethorphan HBr 60 mg Cough suppressant Guaifenesin 1200 mg Expectorant
Inactive Ingredients
Inactive ingredients carbomer homopolymer colloidal silicon dioxide hypromellose magnesium stearate maltodextrin microcrystalline cellulose povidone (K-30) stearic acid
Strengths
60 mg 1200 mg
Quantities
28 tablet
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
Pill Appearance
Shape: oval Color: white Imprint: 053

Identifiers & Packaging

Container Type BOX
UNII
9D2RTI9KYH 495W7451VQ
Packaging

PRINCIPAL DISPLAY PANEL - 28 Tablet Blister Pack Carton † Compare To the active ingredients of Maximum Strength Mucinex ® DM NDC 51660-110-86 Ohm Laboratories Inc. Maximum Strength Guaifenesin 1200 mg & Dextromethorphan HBr 60 mg Extended-Release Tablets Expectorant & Cough Suppressant 12 Hour Controls Cough Thins and Loosens Mucus Immediate and Extended Release 28 Extended-Release Tablets GuaDM-28s

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 28 Tablet Blister Pack Carton † Compare To the active ingredients of Maximum Strength Mucinex ® DM NDC 51660-110-86 Ohm Laboratories Inc. Maximum Strength Guaifenesin 1200 mg & Dextromethorphan HBr 60 mg Extended-Release Tablets Expectorant & Cough Suppressant 12 Hour Controls Cough Thins and Loosens Mucus Immediate and Extended Release 28 Extended-Release Tablets GuaDM-28s

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

Active ingredients (in each extended-release tablet) Purposes Dextromethorphan HBr 60 mg Cough suppressant Guaifenesin 1200 mg Expectorant

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).

Storage & Handling

Other information Store between 20-25°C (68-77°F)

Questions

Questions? (1-800-406-7984) You may also report side effects to this phone number.


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