Guaifenesin and Dextromethorphan HBr GUAIFENESIN AND DEXTROMETHORPHAN HBR AMNEAL PHARMACEUTICALS LLC 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
ANDA209692

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient(s) (in each extended-release tablet) Active ingredient (in each extended-release tablet) Dextromethorphan HBr 60 mg Guaifenesin 1200 mg
Inactive Ingredients
Inactive ingredients carbomer colloidal silicon dioxide D&C yellow #10 aluminum lake hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose povidone and talc
Strengths
60 mg 1200 mg
Quantities
1 count
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: yellow Imprint: AN039

Identifiers & Packaging

Container Type BOX
UPC
0365162039030
UNII
9D2RTI9KYH 495W7451VQ
Packaging

Principal Display Panel 1200mg Blister Pack 1 2

Package Descriptions
  • Principal Display Panel 1200mg Blister Pack 1 2

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 1200 mg/60 mg do not crush, chew, or break 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 tablet every 12 hours; not more than 2 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

Purpose Guaifenesin - Expectorant Dextromethorphan HBr - 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? 1-877-835-5472 You may also report side effects to this phone number. Parents: Learn about teen medicine abuse www.StopMedicine Abuse.org Keep the carton. It contains important information. See end panel for expiration date. †Mucinex® is a registered trademark of Reckitt Benckiser LLC. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 04-2018-01


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