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  5. Label Information: Guaifenesin

FDA Label for Guaifenesin

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. KEEP OUT OF REACH OF CHILDREN
    4. USES
    5. WARNINGS
    6. DIRECTIONS
    7. INACTIVE INGREDIENTS
    8. QUESTIONS

Guaifenesin Product Label

The following document was submitted to the FDA by the labeler of this product Ohm 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



(in each extended-release tablet)

Guaifenesin, USP


Purpose



Expectorant


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).


Uses



  • •Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bronchial 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 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.


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 over 12 years of age and over: one or two extended-release tablets every 12 hours. Do not exceed 4 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.

      • Keep the carton. It contains important information. See end panel for expiration date.

      †Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.


Inactive Ingredients



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


Questions



call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.


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