Mucus Relief Dm Tablet
FDA Label NDC 80513-407

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Llc for the product Mucus Relief Dm (NDC 80513-407). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg

Purpose

Cough suppressant

Expectorant

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

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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222).

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 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.

Questions?

call toll free  1-800-630-8895

Distributed By:

ADVANCED RX LLC

1942 NE 163ST North Miami Beach,

FL 33162 U.S.A

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.

Label (Label)

Label (Label)

* Please review the disclaimer below.