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  5. Label Information: Guaifenesin

FDA Label for Guaifenesin

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. STOP USE AND ASK A DOCTOR IF
    6. IF PREGNANT OR BREAST-FEEDING,
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS?
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Guaifenesin Product Label

The following document was submitted to the FDA by the labeler of this product Pharbest Pharmaceuticals, Inc.. 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.

Active Ingredient (In Each Tablet)



Guaifenesin 400mg


Purpose



Expectorant


Uses



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

Warnings



Ask 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 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



  • take with a full glass of water
  • this product can be administered without regard for the timing of the meals
  • do not exceed 6 doses in 24 hours or as directed by doctor

    • adults and children 12 years of age and over

    take 1 tablet every 4 hours as needed

    children 6 to under 12 years of age

    take ½ tablet every 4 hours as needed

    children under 6 years of age

    consult a doctor


Other Information



  • store at room temperature (15°-30°C)

Inactive Ingredients



magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, stearic acid.


Questions?



Adverse drug event call (866) 562-2756 Mon-Fri: 8 AM to 4 PM


Package Label.Principal Display Panel



PHARBEST 

NDC 16103-379-04

Manufactured in the USA

Immediate Release

*COMPARE TO the active ingredient in MUCINEX® Tablets

PHARBINEX

Guaifenesin 400mg each

Expectorant

30 TABLETS


* Please review the disclaimer below.