Guaifenesin And Dextromethorpham Hbr Extended-release Tablets, 1200 Mg/60 Mg

Guaifenesin And Dextromethorpham Hbr Extended-release Tablets, 1200 Mg/60 Mg
SPL v15
SPL
SPL Set ID cfdbcdb0-531a-4d95-ac5d-64d6d034b252
Route
ORAL
Published
Effective Date 2024-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (1200 mg) Dextromethorphan (60 mg)
Inactive Ingredients
Carbomer Homopolymer Type A Silicon Dioxide D&c Yellow No. 10 Hypromelloses Lactose Monohydrate Magnesium Stearate Cellulose, Microcrystalline Talc Povidone

Identifiers & Packaging

Pill Appearance
Imprint: AN039 Shape: oval Color: yellow Size: 22 mm Score: 1
Marketing Status
ANDA Active Since 2018-11-01

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

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