Mucus Relief Dm

Mucus Relief Dm
SPL v2
SPL
SPL Set ID 3ce0f096-906e-47eb-8061-0ac1e9d8ea55
Route
ORAL
Published
Effective Date 2024-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Microcrystalline Cellulose Sodium Starch Glycolate Type A Stearic Acid Silicon Dioxide Magnesium Stearate Hypromellose, Unspecified Polyethylene Glycol, Unspecified D&c Yellow No. 10 Aluminum Lake

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-04

Description

Dextromethorphan HBr 20 mg Guaifenesin 400mg

Purpose

Dextromethorphan HBr 20 mg ......................................... Cough suppressant Guaifenesin 400mg ........................................................................ Expectorant


Medication Information

Purpose

Dextromethorphan HBr 20 mg ......................................... Cough suppressant

Guaifenesin 400mg ........................................................................ Expectorant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400mg

Uses:

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

• temporarily relieves

   o cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

   o the intensity of coughing

   o the impulse to cough to help you get to sleep

Section 42229-5

This product is not manufactured or distributed by Reckitt Benckiser’s, owner of the registered trademark MUCINEX DM® Tablets.

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222).

Section 51945-4

Section 53414-9

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

Warnings:

Do Not Use
  • for children under 12 year 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:

Adults and children 12 years of age and older: Take 1 tablet every 4 hours with a full glass of water. Do not exceed 6 doses in 24 hours.

Children under 12 years of age: Do not use

Other Information: 

Store between 20ºC-25ºC (68ºF-77ºF).

  • Keep in a dry place and do not expose to heat 
  • do not use if imprinted safety seal under cap is broken or missing.
Inactive Ingredients:

microcrystalline cellulose, sodium starch glycolate, stearic acid powder, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, D&C yellow

Questions Or Comments?

Call (732) 698-5070 Monday through Friday 9 AM to 5 PM EST or www.pioneerlifesciences.com

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 sign of serious illness.

Active Ingredient (in Each Tablet)

Dextromethorphan HBr 20 mg

Guaifenesin 400mg

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: (USES:)

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

• temporarily relieves

   o cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

   o the intensity of coughing

   o the impulse to cough to help you get to sleep

Section 42229-5 (42229-5)

This product is not manufactured or distributed by Reckitt Benckiser’s, owner of the registered trademark MUCINEX DM® Tablets.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222).

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Purpose

Dextromethorphan HBr 20 mg ......................................... Cough suppressant

Guaifenesin 400mg ........................................................................ Expectorant

Warnings: (WARNINGS:)

Do Not Use (Do not use)
  • for children under 12 year 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: (DIRECTIONS:)

Adults and children 12 years of age and older: Take 1 tablet every 4 hours with a full glass of water. Do not exceed 6 doses in 24 hours.

Children under 12 years of age: Do not use

Other Information:  (OTHER INFORMATION: )

Store between 20ºC-25ºC (68ºF-77ºF).

  • Keep in a dry place and do not expose to heat 
  • do not use if imprinted safety seal under cap is broken or missing.
Inactive Ingredients: (INACTIVE INGREDIENTS:)

microcrystalline cellulose, sodium starch glycolate, stearic acid powder, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, D&C yellow

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call (732) 698-5070 Monday through Friday 9 AM to 5 PM EST or www.pioneerlifesciences.com

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 sign of serious illness.

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Dextromethorphan HBr 20 mg

Guaifenesin 400mg

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)