Guaifenesin and Dextromethorphan HBr GUAIFENESIN AND DEXTROMETHORPHAN HBR SUN PHARMACEUTICAL INDUSTRIES, 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) Dextromethorphan HBr 60 mg Guaifenesin 1200 mg
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
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 UNKNOWN
UNII
495W7451VQ 9D2RTI9KYH
Packaging

Package/Label Principal Display Panel NDC 63304-110-14 Maximum Strength Guaifenesin & Dextromethorphan HBr Extended-Release Tablets 1200 mg/60 mg Expectorant & Cough Suppressant 12 Hour • Controls Cough • Thins and Loosens Mucus • Immediate and Extended Release 14 Extended-Release Tablets SUN PHARMA spl-guai-dextro-label; Package/Label Principal Display Panel NDC 63304-106-21 Guaifenesin & Dextromethorphan HBr Extended-Release Tablets 600 mg/30 mg Expectorant & Cough Suppressant 12 Hour • Controls Cough • Thins and Loosens Mucus • Immediate and Extended Release 20 Extended-Release Tablets SUN PHARMA spl-guai-dextro-label2

Package Descriptions
  • Package/Label Principal Display Panel NDC 63304-110-14 Maximum Strength Guaifenesin & Dextromethorphan HBr Extended-Release Tablets 1200 mg/60 mg Expectorant & Cough Suppressant 12 Hour • Controls Cough • Thins and Loosens Mucus • Immediate and Extended Release 14 Extended-Release Tablets SUN PHARMA spl-guai-dextro-label
  • Package/Label Principal Display Panel NDC 63304-106-21 Guaifenesin & Dextromethorphan HBr Extended-Release Tablets 600 mg/30 mg Expectorant & Cough Suppressant 12 Hour • Controls Cough • Thins and Loosens Mucus • Immediate and Extended Release 20 Extended-Release Tablets SUN PHARMA spl-guai-dextro-label2

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

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. Pregnancy or Breast Feeding 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 Cough suppressant 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).


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