Maximum Strength Mucus Relief Tablet, Extended Release
FDA Label NDC 70677-1320

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Maximum Strength Mucus Relief (NDC 70677-1320). 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 1200 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 tablet every 12 hour.  Do not exceed 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 to 25°C (68 to 77°F)

Inactive Ingredients

carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

Questions?

Call 833-358-6131 Monday to Friday 9:00 am to 7:00 pm EST.

Principal Display Panel

NDC 70677-1320-1

COMPARE TO MUCINEX® MAXIMUM STRENGTH EXTENDED-RELEASE 1200 MG TABLETS ACTIVE INGREDIENT*

Foster & Thrive

MAXIMUM STRENGTH 12 HOUR

Mucus Relief

Guaifenesin Extended-Release Tablets 1200 mg

EXPECTORANT

Relieves:

  • Chest Congestion
  • Thins and Loosens Mucus

    • 14 EXTENDED-RELEASE TABLETS

    234-14-ft.jpg (234 14 Ft)

    234-14-ft.jpg (234 14 Ft)

* Please review the disclaimer below.