Guaifenesin And Dextromethorphan Hbr

Guaifenesin And Dextromethorphan Hbr
SPL v2
SPL
SPL Set ID f2eb5494-2672-444f-afa3-d1ef8ed1eaa1
Route
ORAL
Published
Effective Date 2021-08-30
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: 054 Shape: oval Color: white Size: 16 mm Score: 1
Marketing Status
ANDA Active Since 2021-07-01

Description

Drug Facts


Medication Information

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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).

Section 53414-9

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

Section 55105-1
Active ingredients (in each extended-release tablet) Purposes
Dextromethorphan HBr 30 mg Cough suppressant
Guaifenesin 600 mg 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 or 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours
  • children under 12 years of age: do not use
Questions?

(1-800-406-7984)

You may also report side effects to this phone number.

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
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.
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)
Principal Display Panel 40 Tablet Blister Pack Carton

Compare To

the active ingredients of

Mucinex® DM

NDC 51660-301-41

ohm®

Guaifenesin 600 mg

& Dextromethorphan HBr 30 mg

Extended-Release Tablets

Expectorant & Cough Suppressant

12 Hour

  • Controls Cough
  • Thins and Loosens Mucus
  • Immediate and Extended Release

40 Extended-Release Tablets


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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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).

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in each extended-release tablet) Purposes
Dextromethorphan HBr 30 mg Cough suppressant
Guaifenesin 600 mg 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 or 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours
  • children under 12 years of age: do not use
Questions?

(1-800-406-7984)

You may also report side effects to this phone number.

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
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.
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)
Principal Display Panel 40 Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 40 Tablet Blister Pack Carton)

Compare To

the active ingredients of

Mucinex® DM

NDC 51660-301-41

ohm®

Guaifenesin 600 mg

& Dextromethorphan HBr 30 mg

Extended-Release Tablets

Expectorant & Cough Suppressant

12 Hour

  • Controls Cough
  • Thins and Loosens Mucus
  • Immediate and Extended Release

40 Extended-Release Tablets


Advanced Ingredient Data


Raw Label Data

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