drug facts

drug facts
SPL v3
SPL
SPL Set ID 10eda178-a9cf-685c-e063-6294a90ae5ec
Route
oral
Published
Effective Date 2025-09-25
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
guaifenesin (600 mg) dextromethorphan (30 mg)
Inactive Ingredients
silicon dioxide hypromellose, unspecified magnesium stearate microcrystalline cellulose povidone k90 povidone k25 starch, corn

Identifiers & Packaging

Pill Appearance
Imprint: X;62 Shape: oval Color: white Size: 16 mm Score: 1
Marketing Status
anda active Since 2024-05-15

Purpose

Cough suppressant Expectorant

Description

Dextromethorphan Hydrobromide USP 30 mg Guaifenesin USP 600 mg


Medication Information

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.
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

Cough suppressant Expectorant

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
Other Information


  • store at 20° to 25°C (68° to 77°F)
Inactive Ingredients


colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)

Description

Dextromethorphan Hydrobromide USP 30 mg Guaifenesin USP 600 mg

Questions?

call 1-855-274-4122



DISTRIBUTED BY:

AMAZON.COM SERVICES LLC

410 TERRY AVENUE N., SEATTLE, WA 98109



Made in India

Purposes

Cough suppressant

Expectorant

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 (1-800-222-1222) right away.

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)
Active Ingredients (in Each Extended Release Tablet)

Dextromethorphan Hydrobromide USP 30 mg

Guaifenesin USP 600 mg

Package Label Principal Display Panel 30 Mg/600 Mg (40 Tablet Carton Label)

amazon

basic+care

Extended-Release

Tablets

Compare to

Mucinex® DM

active ingredients*

NDC 72288-220-08

Mucus-DM

Dextromethorphan HBr and Guaifenesin

Extended-release Tablets

30 mg/600 mg

Dextromethorphan HBr 30 mg - Cough Suppressant

Guaifenesin 600 mg - Expectorant 

RELIEVES COUGH & CHEST CONGESTION

12 Hour

• Controls Cough

• Thins & Loosens Mucus

actual size

40 (4 x 10)

EXTENDED-RELEASE TABLETS




Structured Label Content

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.
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


  • 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
Other Information (Other information)


  • store at 20° to 25°C (68° to 77°F)
Inactive Ingredients (Inactive ingredients)


colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)

Questions?

call 1-855-274-4122



DISTRIBUTED BY:

AMAZON.COM SERVICES LLC

410 TERRY AVENUE N., SEATTLE, WA 98109



Made in India

Purposes

Cough suppressant

Expectorant

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, 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 (1-800-222-1222) right away.

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

Dextromethorphan Hydrobromide USP 30 mg

Guaifenesin USP 600 mg

Package Label Principal Display Panel 30 Mg/600 Mg (40 Tablet Carton Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 30 mg/600 mg (40 Tablet Carton Label))

amazon

basic+care

Extended-Release

Tablets

Compare to

Mucinex® DM

active ingredients*

NDC 72288-220-08

Mucus-DM

Dextromethorphan HBr and Guaifenesin

Extended-release Tablets

30 mg/600 mg

Dextromethorphan HBr 30 mg - Cough Suppressant

Guaifenesin 600 mg - Expectorant 

RELIEVES COUGH & CHEST CONGESTION

12 Hour

• Controls Cough

• Thins & Loosens Mucus

actual size

40 (4 x 10)

EXTENDED-RELEASE TABLETS




Advanced Ingredient Data


Raw Label Data

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