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  5. Label Information: Guaifenesin

FDA Label for Guaifenesin

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(S)
    2. PURPOSE
    3. USE(S)
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. STOP USE AND ASK DOCTOR IF
    7. PREGNANCY/BREASTFEEDING
    8. KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS
    13. PRINCIPAL DISPLAY PANEL

Guaifenesin Product Label

The following document was submitted to the FDA by the labeler of this product Granules India Ltd. 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(S)



Guaifenesin 600 mg (for 600mg)
 
Guaifenesin 1200 mg (for 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

Warnings




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 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.

Pregnancy/Breastfeeding



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 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(For 600mg)
  • adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.(For 1200mg)
  • 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; hypromellos, magnesium stearate,  microcrystalline cellulose, sodium starch glycolate


Questions Or Comments




Contact 1-877-770-3183
Mon-Fri 8:00 AM EST to 5:00 PM PST.

All trademarks are property of their respective owners.MUCINEX is the registered trademark of Reckitt Benckiser LLC.


Principal Display Panel



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