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  5. Label Information: Guaifenesin 1200 Mg

FDA Label for Guaifenesin 1200 Mg

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(S)
    2. PURPOSE
    3. USE(S)
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF
    7. STOP USE AND ASK DOCTOR IF
    8. IF PREGNANCY/BREASTFEEDING,
    9. KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. PRINCIPAL DISPLAY PANEL- 600MG CARTON
    15. PRINCIPAL DISPLAY PANEL - 1200 MG CARTON

Guaifenesin 1200 Mg Product Label

The following document was submitted to the FDA by the labeler of this product Dr. Reddy's Laboratories 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(S)



Guaifenesin 600 mg (for 600mg)

Guaifenesin 1200 mg (for 1200 mg)


Purpose



Expectorant


Use(S)



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

Warnings



Applicable warning(s) in 201.66(c)(5)(i) and (ii)


Do Not Use



  • For children under 12 years age

Ask A Doctor Before Use If



  • 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.

If Pregnancy/Breastfeeding,



ask a health professional before use.


Keep Out Of Reach Of Children



In case of overdose, get medical help or contact aPoison 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: 1or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours (for 600 mg)
  • 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 (for 1200 mg)
  • children under 12 years of age: do not use

Other Information



  • store at 20-25°C (68-77°F)

Inactive Ingredients



carbomer homopolymer type B, colloidal silicon dioxide, ferric oxide red, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate type A


Questions?



call 1-888-375-3784 Weekdays (9am - 8pm EST)

You may also report side effects to this phone number.


Principal Display Panel- 600Mg Carton



Guaifenesin Extended-Release Tablets 600 mg Carton Label


Principal Display Panel - 1200 Mg Carton



Guaifenesin Extended-Release Tablets 1200 mg Carton Label


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