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  5. Label Information: Mucinex Maximum Strength

FDA Label for Mucinex Maximum Strength

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH EXTENDED-RELEASE BI-LAYER TABLET)
    3. PURPOSE
    4. USES
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. PRINCIPAL DISPLAY PANEL - 14 TABLET BLISTER PACK CARTON

Mucinex Maximum Strength Product Label

The following document was submitted to the FDA by the labeler of this product Rb Health (us) Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224

Made in England


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



Guaifenesin 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


Otc - Do Not Use



Do not use

  • for children under 12 years of age

Otc - Ask Doctor



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)

Otc - Stop Use



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.


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 hours. 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 20-25°C (68-77°F)

Inactive Ingredients



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


Questions?



1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.


Principal Display Panel - 14 Tablet Blister Pack Carton



MAXIMUM STRENGTH

NDC 63824-023-35

Mucinex®

1200 mg guaifenesin
extended-release bi-layer tablets

EXPECTORANT

12
HOUR

  • ✓Relieves Chest Congestion
  • ✓Thins and Loosens Mucus
  • ✓Immediate and Extended Release

    • 14
    EXTENDED-RELEASE
    BI-LAYER TABLETS


* Please review the disclaimer below.