Mucus Relief Tablet, Extended Release
FDA Label NDC 71335-2642

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bryant Ranch Prepack for the product Mucus Relief (NDC 71335-2642). 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 extended-release tablet), purpose, use(s), warning, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant 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 600 mg

Purpose

Expectorant

Use(S)

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

Warning

.

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.

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 tablet
  • 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 tablets every 12 hours.  
  • Do not exceed 4 tablets in 24 hours.
  • children under 12 years of age: do not use

Other Information

  • tamper evident: do not use if seal on the bottle printed "SEALED for YOU PROTECTION" is broken or missing. 
  • store between 20 to 25°C (68 to 77°F)

Inactive Ingredients

carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

Questions?

1-800-616-2471

You may also report side effects to this phone number. 

How Supplied

Guaifenesin 600 mg: color white, shape capsule and the imprint code is G233.

NDC: 71335-2642-1: 30 EXTENDED RELEASE TABLETs in a BOTTLE

NDC: 71335-2642-2: 20 EXTENDED RELEASE TABLETs in a BOTTLE

NDC: 71335-2642-3: 60 EXTENDED RELEASE TABLETs in a BOTTLE

NDC: 71335-2642-4: 40 EXTENDED RELEASE TABLETs in a BOTTLE

NDC: 71335-2642-5: 14 EXTENDED RELEASE TABLETs in a BOTTLE

NDC: 71335-2642-6: 6 EXTENDED RELEASE TABLETs in a BOTTLE

Store between 20 to 25°C (68 to 77°F)

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

Package Label.Principal Display Panel

Guaifenesin ER 600mg Tablet

Label (Lbl713352642)

Label (Lbl713352642)

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