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  5. Label Information: Clemastine Fumarate

FDA Label for Clemastine Fumarate

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. KEEP OUT OF REACH OF CHILDREN.
    4. USES
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. IF PREGNANT OR BREAST-FEEDING,
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. PRINCIPAL DISPLAY PANEL

Clemastine Fumarate Product Label

The following document was submitted to the FDA by the labeler of this product Physicians Total Care, 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



Clemastine fumarate 1.34 mg (equivalent to 1 mg clemastine)


Purpose



Antihistamine


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away.


Uses



Temporarily relieves these symptoms of the common cold, hay fever, or other upper respiratory allergies:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat

Ask A Doctor Before Use If You Have



  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are



taking sedatives or tranquilizers.


When Using This Product



  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Directions



adults and children 12 years and older:

1 tablet every 12 hours; not more than 2 tablets in 24 hours

children under 12 years:

ask a doctor


Other Information



  • Safety sealed: do not use if the imprinted bottle seal is open or torn.
  • Store at 20°-25°C (68°-77°F).

Inactive Ingredients



Hydroxypropyl methylcellulose, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and starch (corn).


Questions Or Comments?



1-800-525-8747


Principal Display Panel



Clemastine Fumarate 1.34 mg Label - 5913

Clemastine Fumarate 1.34 mg Label - 5913

NDC 54868-5913-0

Clemastine

Fumarate

Tablets, USP

1.34 mg

100 Tablets


Antihistamine

12 Hour Relief

Relief of: Sneezing Runny Nose

Itchy, Watery Eyes




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