Guaifenesin Extended-release Tablet, Multilayer, Extended Release
FDA Label NDC 68094-048

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Precision Dose Inc. for the product Guaifenesin Extended-release (NDC 68094-048). 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, active ingredient (in each extended-release bi-layer caplet), purpose, uses, 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

Other

Drug Facts

Gluten Free

Distributed by:
Perrigo
Allegan, MI 49010

Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email [email protected]

LI1382 Rev. 06/21

Active Ingredient (In Each Extended-Release Bi-Layer Caplet)

Guaifenesin 600 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

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.

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

  • Use as directed per healthcare professional.
  • do not crush, chew, or break caplet
  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • adults and children 12 years of age and over: 1 or 2 caplets every 12 hours. Do not exceed 4 caplets in 24 hours.
  • children under 12 years of age: do not use

Other Information

  • store between 20-25°C (68-77°F)

Inactive Ingredients

Carbomer homopolymer type B, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions Or Comments?

1-800-397-9228

How Supplied

NDC 68094-048-61
Unit Dose Packages of 100 Tablets (10×10) per Carton

Principal Display Panel - 600 Mg Blister Pack Carton

PrecisionDose™

NDC 68094-048-61
Unit Dose

guaiFENesin
Extended-Release
Tablets,

600 mg

100 Tablets
(10 x 10)

(in each extended-release tablet)
Guaifenesin 600 mg....Expectorant.

Directions: do not crush, chew, or
break tablet take with a full glass of water

Unique Bi-Layer Tablet
GLUTEN FREE

USUAL DOSE: See Enclosed Drug Facts
Store at 20-25°C (68-77°F)

Keep out of reach of children.
Hospital Use Only.

LC1384
R0

Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080

Principal Display Panel (600 mg Blister Pack Carton)

Principal Display Panel (600 mg Blister Pack Carton)

* Please review the disclaimer below.