Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 06328741-03e3-49cf-ae44-d4c2116e38a3
Route
ORAL
Published
Effective Date 2022-12-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (600 mg) Dextromethorphan (30 mg)
Inactive Ingredients
Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Silicon Dioxide Maltodextrin Povidone K30 Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: 053 Shape: oval Color: white Size: 16 mm Size: 22 mm Score: 1
Marketing Status
ANDA Active Since 2021-07-01

Description

Dextromethorphan HBr 60 mg Guaifenesin 1200 mg

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant Expectorant

Description

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
Purposes

Cough suppressant

Expectorant

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.
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)
Inactive Ingredients

carbomer homopolymer, colloidal silicon dioxide, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), stearic acid

When Using This Product
  • Do not use more than directed
Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

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

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)
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

Active Ingredients (in Each Extended Release Tablet)

Dextromethorphan HBr 60 mg

Guaifenesin 1200 mg


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
Purposes

Cough suppressant

Expectorant

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.
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 (Other information)
  • Store between 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

carbomer homopolymer, colloidal silicon dioxide, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), stearic acid

When Using This Product (When using this product)
  • Do not use more than directed
Pregnancy Or Breast Feeding (Pregnancy or Breast Feeding)

If pregnant or breast-feeding, ask a health professional before use.

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.
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)
Package/label Principal Display Panel (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

Active Ingredients (in Each Extended Release Tablet) (Active ingredients (in each extended-release tablet))

Dextromethorphan HBr 60 mg

Guaifenesin 1200 mg


Advanced Ingredient Data


Raw Label Data

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