Guaifenesin And Dextromethorpham Hbr Extended-release Tablets, 1200 Mg/60 Mg
cfdbcdb0-531a-4d95-ac5d-64d6d034b252
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredient (in each extended-release tablet) Dextromethorphan HBr 60 mg Guaifenesin 1200 mg
Purpose
Guaifenesin - Expectorant Dextromethorphan HBr - Cough suppressant
Medication Information
Purpose
Guaifenesin - Expectorant
Dextromethorphan HBr - Cough suppressant
Description
Active ingredient (in each extended-release tablet) Dextromethorphan HBr 60 mg Guaifenesin 1200 mg
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
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
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.
Questions?
1-877-835-5472
You may also report side effects to this phone number.
Parents:
Learn about teen medicine abuse
www.StopMedicineAbuse.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
Other Information
- Bottle: Tamper evident: Do not use if carton is open or if printed foil under cap is broken or missing
- Blister: Do not use if carton is open or if printed seal with product name on blister is broken or missing
- store between 20° to 25°C (68° to 77°F)
Active Ingredient(s)
Active ingredient (in each extended-release tablet)
Dextromethorphan HBr 60 mg
Guaifenesin 1200 mg
Inactive Ingredients
carbomer, colloidal silicon dioxide, D&C yellow #10 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and talc
Principal Display Panel
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)
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)
Structured Label Content
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
Purpose
Guaifenesin - Expectorant
Dextromethorphan HBr - Cough suppressant
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
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.
Questions?
1-877-835-5472
You may also report side effects to this phone number.
Parents:
Learn about teen medicine abuse
www.StopMedicineAbuse.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
Other Information (Other information)
- Bottle: Tamper evident: Do not use if carton is open or if printed foil under cap is broken or missing
- Blister: Do not use if carton is open or if printed seal with product name on blister is broken or missing
- store between 20° to 25°C (68° to 77°F)
Active Ingredient(s) (Active ingredient(s))
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
Principal Display Panel
When Using This Product (When using this product)
- do not use more than directed
Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)
ask a health professional before use.
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)
Ask A Doctor Before Use If You Have (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)
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:04:03.009352 · Updated: 2026-03-14T23:04:28.287489