Guaifenesin Tablet, Extended Release
FDA Label NDC 68196-960

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 (NDC 68196-960). 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, purpose, uses, warnings, otc - do not use, ask a doctor before use if you have, 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

Active Ingredient

(in each extended-release tablet)

Guaifenesin USP 1200 mg

Purpose

Expectorant

Uses

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

Warnings

Do not use

Otc - Do Not Use

  • for children under 12 years of age

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)

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.

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 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 of age and over: 1 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours.
  • children under 12 years of age: do not use

Other Information

  • store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

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

Questions?

1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

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

Made in India

Package Label-Principal Display Panel - 1200 Mg Blister Carton (56 (4 X 14) Tablets)

Member's
Mark™

COMPARE TO MAXIMUM STRENGTH
MUCINEX® ACTIVE INGREDIENT*

NDC 68196-960-56

MAXIMUM STRENGTH

Mucus Relief
GUAIFENESIN EXTENDED-RELEASE TABLETS, 1200 mg
GUAIFENESIN 1200 mg-EXPECTORANT

Relieves chest congestion

Actual Size

56
Extended-Release
Tablets

  • Relieves chest congestion
  • Thins and loosens mucus

    • 12
    HR 



    Package Label-principal Display Panel (1200 mg Blister Carton (56 (4 x 14) Tablets))

    Package Label-principal Display Panel (1200 mg Blister Carton (56 (4 x 14) Tablets))

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