Guaifenesin And Dextromethorphan Hydrobromide
FDA Label NDC 68196-073

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sam's West Inc for the product Guaifenesin And Dextromethorphan Hydrobromide (NDC 68196-073). 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 other, otc - purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

DISTRIBUTED BY:
SAM'S WEST, INC.
BENTONVILLE, AR 72716

Otc - Purpose

Active ingredients (in each extended-release tablet)Purposes
Dextromethorphan HBr 60 mgCough suppressant
Guaifenesin 1200 mgExpectorant

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

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.

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)

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.

Otc - Pregnancy Or Breast Feeding

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 overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • do not crush, chew, or break 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 tablet every 12 hours; not more than 2 tablets in 24 hours
  • children under 12 years of age: do not use

Other Information

  • Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
  • store between 20-25°C (68-77°F)

Inactive Ingredients

carbomer homopolymer type B; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Questions?

(1-800-406-7984)

You may also report side effects to this phone number.

Principal Display Panel - 1200 Mg/60 Mg Tablet Blister Pack Carton

Compare to Maximum Strength
Mucinex® DM active ingredients*

NDC 68196-073-56

Member's Mark™

12
HOUR

Maximum Strength
Mucus Relief DM

Guaifenesin 1200 mg &
Dextromethorphan HBr 60 mg
Extended-Release Tablets
Expectorant & Cough Suppressant

  • Controls cough
  • Thins and
    loosens mucus
  • Immediate and
    Extended Release

    • actual size

    56
    Extended-
    Release
    Tablets

    Principal Display Panel (1200 mg/60 mg Tablet Blister Pack Carton)

    Principal Display Panel (1200 mg/60 mg Tablet Blister Pack Carton)

* Please review the disclaimer below.