Mucus Relief Dm

Mucus Relief Dm
SPL v1
SPL
SPL Set ID 64620186-a45b-4c35-a3b9-a347348f93f7
Route
ORAL
Published
Effective Date 2025-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Silicon Dioxide Hypromellose 2910 (5 Mpa.s) Hypromellose 2910 (15 Mpa.s) Methylcellulose, Unspecified Magnesium Stearate Maltodextrin Microcrystalline Cellulose Polyethylene Glycol 400 Povidone K30 Water Sodium Starch Glycolate Type A Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: ET16 Shape: oval Color: white Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant

Expectorant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 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
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).

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 a MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough is accompanied by excessive phlegm (mucus)

Ask a doctor or pharmcists before use if you are takingsedatives or tranquilizers

When using this productdo not use more than directed

Stop use and ask a doctor ifcough 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.

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
Questions?

call toll free  1-800-630-8895

Distributed By:

ADVANCED RX LLC

1942 NE 163ST North Miami Beach,

FL 33162 U.S.A

Other Information
  • store between 20° - 25°C (68° - 77°F)
  • Keep in dry place and do not expose to heat
  • do not use if imprinted safety seal under the cap is broken or missing.
Inactive Ingredients

Colloidal Silicon Dioxide, Hypromellose 5 & 15, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, PEG 400, PVP K30, Purified Water, Sodium Starch Glycolate, Stearic Acid Powder.

Principal Display Panel

NDC 80513-407-09

*Compare to Mucine ® DM active ingredients

Mucus Relief DM

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Cough Suppresant & Expectorant

90 Tablets

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Mucinex ® DM Tablets.

Active Ingredient (in Each Tablet)

Dextromethorphan HBr 20 mg

Guaifenesin 400 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
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).

Purpose

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 a MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough is accompanied by excessive phlegm (mucus)

Ask a doctor or pharmcists before use if you are takingsedatives or tranquilizers

When using this productdo not use more than directed

Stop use and ask a doctor ifcough 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.

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
Questions?

call toll free  1-800-630-8895

Distributed By: (Distributed by:)

ADVANCED RX LLC

1942 NE 163ST North Miami Beach,

FL 33162 U.S.A

Other Information (Other information)
  • store between 20° - 25°C (68° - 77°F)
  • Keep in dry place and do not expose to heat
  • do not use if imprinted safety seal under the cap is broken or missing.
Inactive Ingredients (Inactive ingredients)

Colloidal Silicon Dioxide, Hypromellose 5 & 15, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, PEG 400, PVP K30, Purified Water, Sodium Starch Glycolate, Stearic Acid Powder.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 80513-407-09

*Compare to Mucine ® DM active ingredients

Mucus Relief DM

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Cough Suppresant & Expectorant

90 Tablets

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Mucinex ® DM Tablets.

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

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg


Advanced Ingredient Data


Raw Label Data

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