SPL v8
SPL
SPL Set ID b7e9477d-33d9-4463-b8a6-69af5f71ce35
Route
ORAL
Published
Effective Date 2014-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (60 mg)
Inactive Ingredients
Anhydrous Lactose Silicon Dioxide Starch, Corn Croscarmellose Sodium Lactose Monohydrate Stearic Acid Hypromellose, Unspecified Polyethylene Glycol, Unspecified Ferric Oxide Red Titanium Dioxide Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance
Imprint: SG;202 Shape: oval Shape: capsule Color: pink Size: 12 mm Size: 17 mm Score: 1
Marketing Status
ANDA Active Since 2014-12-26

Description

Fexofenadine HCl USP 60 mg Fexofenadine HCl USP 180 mg

Purpose

Antihistamine


Medication Information

Indications and Usage

Uses

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

Purpose

Antihistamine

Description

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
Section 50565-1

Keep out of reach of children.

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

Section 50567-7

Severe Allergy Warning:Get emergency help immediatelyif 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.

Section 51945-4

Manufactured by:

ScieGen Pharmaceuticals, Inc.

Hauppauge, NY 11788 USA

Section 53414-9

If pregnant or breast-feeding,

ask a health professional before use.

Do Not Use

to preventhives 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

    Hives

Fexofenadine HCl USP 60 mg

Fexofenadine HCl USP 180 mg

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
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.

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

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

Questions Or Comments?

Call toll-free  1-855-724-3436

Manufactured by:

ScieGen Pharmaceuticals, Inc.

Hauppauge, NY 11788 USA

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)
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
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
Package/label Principal Display Panel

Fexofenadine Hydrochloride Tablets USP 60mg

                             Allergy

Fexofenadine HCl USP 60 mg

Fexofenadine HCl USP 180 mg


Structured Label Content

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
Indications and Usage (34067-9)

Uses

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

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50567-7 (50567-7)

Severe Allergy Warning:Get emergency help immediatelyif 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.

Section 51945-4 (51945-4)

Manufactured by:

ScieGen Pharmaceuticals, Inc.

Hauppauge, NY 11788 USA

Section 53414-9 (53414-9)

If pregnant or breast-feeding,

ask a health professional before use.

Purpose

Antihistamine

Do Not Use (Do not use)

to preventhives 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

    Hives (    HIVES)

Fexofenadine HCl USP 60 mg

Fexofenadine HCl USP 180 mg

Other Information (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
Inactive Ingredients (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.

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

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

Questions Or Comments? (Questions or comments?)

Call toll-free  1-855-724-3436

Manufactured by:

ScieGen Pharmaceuticals, Inc.

Hauppauge, NY 11788 USA

When Using This Product (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)
Stop Use and Ask A Doctor If (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
Ask A Doctor Before Use If You Have (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
Package/label Principal Display Panel (Package/Label Principal Display Panel)

Fexofenadine Hydrochloride Tablets USP 60mg

                             Allergy (                             ALLERGY)

Fexofenadine HCl USP 60 mg

Fexofenadine HCl USP 180 mg


Advanced Ingredient Data


Raw Label Data

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