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  5. Label Information: Guaifenesin Extended Release

FDA Label for Guaifenesin Extended Release

View Indications, Usage & Precautions

Table of Contents

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

Guaifenesin Extended Release Product Label

The following document was submitted to the FDA by the labeler of this product Kroger Company. 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

DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202


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


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



  • do not crush, chew, or break extended-release 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 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 20-25°C (68-77°F)
  • TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SEAL ON BLISTER IS BROKEN OR MISSING.

Inactive Ingredients



colloidal silicon dioxide, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, povidone.


Principal Display Panel - 14 Tablet Blister Pack Carton



COMPARE TO the active ingredient of
MAXIMUM STRENGTH Mucinex® *See back panel

NDC 30142-962-14

Kroger®

OUR PHARMACIST RECOMMENDED

Maximum Strength
Mucus Relief
ER-Max
Guaifenesin 1200 mg
Extended-Release
Tablets,
EXPECTORANT

* Please review the disclaimer below.