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  5. Label Information: Fexofenadine Hcl

FDA Label for Fexofenadine Hcl

View Indications, Usage & Precautions

Table of Contents

    1. HIVESACTIVE INGREDIENT (IN EACH FILM-COATED TABLET)
    2. PURPOSE
    3. INDICATIONS & USAGE
    4. OTC - WHEN USING
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS (FOR 60MG)
    12. DIRECTIONS (FOR 180MG)
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. ALLERGYACTIVE INGREDIENT (IN EACH FILM-COATED TABLET)
    17. USES
    18. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    19. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Fexofenadine Hcl Product Label

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

Hivesactive Ingredient (In Each Film-Coated Tablet)



Fexofenadine HCl USP 60 mg

Fexofenadine HCl USP 180 mg


Purpose



Antihistamine

Antihistamine


Indications & Usage



Uses

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.


Otc - When Using



Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

  • trouble swallowing
  • dizziness or loss of consciousness
  • swelling of tongue
  • swelling in or around mouth
  • trouble speaking
  • drooling
  • wheezing or problems breathing

    • These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health profession immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

    Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.


Do Not Use



to prevent hives from any known cause such as:

  •  foods
  • insect stings
  • medicines
  • latex or rubber gloves

    • because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

    •If you have ever had an allergic reaction to this product or any of its ingredients

    if you have ever had an allergic reaction to this product or any of its ingredients.


Ask A Doctor Before Use If You Have



  • •kidney disease.Your doctor should determine if you need a different dose.
  • •hives that are an unusual color, look bruised or blistered
  • •hives that do not itch

    • kidney disease. Your doctor should determine if you need a different dose.


When Using This Product



  • do not take more than directed
  • do not take at the same time as aluminum or magnesium antacids
  • do not take with fruit juices (see Directions)
    • do not take more than directed
    • do not take at the same time as aluminum or magnesium antacids
    • do not take with fruit juices (see Directions)

Stop Use And Ask A Doctor If



  • •an allergic reaction to this product occurs. Seek medical help right away.
  • •symptoms do not improve after 3 days of treatment
  • •the hives have lasted more than 6 weeks

    • an allergic reaction to this product occurs. Seek medical help right away.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding,

ask a health professional before use.

If pregnant or breast-feeding,

ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

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

Keep out of reach of children.

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


Directions (For 60Mg)



adults and children 12 years of age and over

take one 60mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours

children under 12 years of age

do not use

adults 65 years of age  and older

ask a doctor

consumers with kidney disease

ask a doctor

adults and children 12 years of age and over

take one 60mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours

children under 12 years of age

do not use

adults 65 years of age  and older

ask a doctor

consumers with kidney disease

ask a doctor


Directions (For 180Mg)



adults and children 12 years of age and over

take one 180mg tablet with water once a day; do not take more than 1 tablet in 24 hours

children under 12 years of age

do not use

adults 65 years of age and older

ask a doctor

consumers with kidney disease

ask a doctor

adults and children 12 years of age and over

take one 180mg tablet with water once a day; do not take more than 1 tablet in 24 hours

children under 12 years of age

do not use

adults 65 years of age and older

ask a doctor

consumers with kidney disease

ask a doctor


Other Information



  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
  • each tablet contains: sodium 2.7mg(for 60 mg), sodium 8.2mg(for 180 mg)
  • this product meets the requirements of USP Dissolution Test 2
  • Tamper Evident: Do not use if imprinted inner safety seal is torn or missing
    • store between 20° and 25°C (68° and 77°F)
    • protect from excessive moisture
    • each tablet contains: sodium 2.7mg(for 60 mg), sodium 8.2mg(for 180 mg)
    • this product meets the requirements of USP Dissolution Test 2
    • Tamper Evident: Do not use if imprinted inner safety seal is torn or missing

Inactive Ingredients



anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, pregelatinized starch(maize), stearic acid, opadry pink 03B84893 containing hypromellose, polyethylene glycol, red iron oxide titanium dioxide and yellow iron oxide.

anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, pregelatinized starch(maize), stearic acid, opadry pink 03B84893 containing hypromellose, polyethylene glycol, red iron oxide titanium dioxide and yellow iron oxide.


Questions Or Comments?



Call toll-free 1-855-724-3436

Manufactured by:

ScieGen Pharmaceuticals, Inc.

Hauppauge, NY 11788 USA

Call toll-free 1-855-724-3436


Allergyactive Ingredient (In Each Film-Coated Tablet)



Fexofenadine HCl USP 60 mg

Fexofenadine HCl USP 180 mg


Uses



temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

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

Package Label.Principal Display Panel



Manufactured by:

ScieGen Pharmaceuticals, Inc.

Hauppauge, NY 11788 USA


Package/Label Principal Display Panel



Fexofenadine Hydrochloride Tablets USP 60mg

ScieGen Pharmaceuticals, Inc. - fexofenadine hives 03

ScieGen Pharmaceuticals, Inc. - fexofenadine hives 03

Fexofenadine Hydrochloride Tablets USP 60mg

Fexofenadine Hydrochloride Tablets USP 180mg

Fexofenadine Hydrochloride Tablets USP 180mg

Fexofenadine Hydrochloride Tablets USP 60mg

Fexofenadine Hydrochloride Tablets USP 60mg

Fexofenadine Hydrochloride Tablets USP 180mg

Fexofenadine Hydrochloride Tablets USP 180mg


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