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fexofenadine hcl by ScieGen Pharmaceuticals, Inc.

Dosage form: tablet, film coated
Ingredients: FEXOFENADINE HYDROCHLORIDE 60mgFEXOFENADINE HYDROCHLORIDE 180mg
Labeler: ScieGen Pharmaceuticals, Inc.
NDC Code: 50228-201

    HIVES
Active ingredient (in each film-coated tablet)

Fexofenadine HCl USP 60 mg

Fexofenadine HCl USP 180 mg

Purpose

Antihistamine

Uses

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

Warnings

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

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

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

If pregnant or breast-feeding,

ask a health professional before use.

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

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

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.

Questions or comments?

Call toll-free 1-855-724-3436

Manufactured by:

ScieGen Pharmaceuticals, Inc.

Hauppauge, NY 11788 USA

                             ALLERGY
Active ingredient (in each film-coated tablet)

Fexofenadine HCl USP 60 mg

Fexofenadine HCl USP 180 mg

Purpose

Antihistamine

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

Warnings

Do not use

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.

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.

If pregnant or breast-feeding,

ask a health professional before use.

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

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

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.

Questions or comments?

Call toll-free 1-855-724-3436

Manufactured by:

ScieGen Pharmaceuticals, Inc.

Hauppauge, NY 11788 USA

Package/Label Principal Display Panel

Fexofenadine Hydrochloride Tablets USP 60mg

Package/Label Principal Display Panel

Fexofenadine Hydrochloride Tablets USP 60mg

Package/Label Principal Display Panel

Fexofenadine Hydrochloride Tablets USP 180mg

Package/Label Principal Display Panel

Fexofenadine Hydrochloride Tablets USP 180mg

Package/Label Principal Display Panel

Fexofenadine Hydrochloride Tablets USP 60mg

Package/Label Principal Display Panel

Fexofenadine Hydrochloride Tablets USP 60mg

Package/Label Principal Display Panel

Fexofenadine Hydrochloride Tablets USP 180mg

Package/Label Principal Display Panel

Fexofenadine Hydrochloride Tablets USP 180mg

FEXOFENADINE HCL 
fexofenadine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50228-201
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE  
SILICON DIOXIDE 
STARCH, CORN  
CROSCARMELLOSE SODIUM 
LACTOSE MONOHYDRATE 
STEARIC ACID 
HYPROMELLOSES 
POLYETHYLENE GLYCOLS 
FERRIC OXIDE RED 
TITANIUM DIOXIDE 
FERRIC OXIDE YELLOW 
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize12mm
FlavorImprint CodeSG;201
Contains    
Packaging
#Item CodePackage Description
1NDC:50228-201-0130 TABLET, FILM COATED in 1 BOTTLE
2NDC:50228-201-021000 TABLET, FILM COATED in 1 BOTTLE
3NDC:50228-201-0330 TABLET, FILM COATED in 1 BOTTLE
4NDC:50228-201-041000 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20450712/26/2014
FEXOFENADINE HCL 
fexofenadine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50228-202
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE  
SILICON DIOXIDE 
STARCH, CORN  
CROSCARMELLOSE SODIUM 
LACTOSE MONOHYDRATE 
STEARIC ACID 
HYPROMELLOSES 
POLYETHYLENE GLYCOLS 
FERRIC OXIDE RED 
TITANIUM DIOXIDE 
FERRIC OXIDE YELLOW 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize17mm
FlavorImprint CodeSG;202
Contains    
Packaging
#Item CodePackage Description
1NDC:50228-202-0130 TABLET, FILM COATED in 1 BOTTLE
2NDC:50228-202-021000 TABLET, FILM COATED in 1 BOTTLE
3NDC:50228-202-0330 TABLET, FILM COATED in 1 BOTTLE
4NDC:50228-202-041000 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20450712/26/2014
Labeler - ScieGen Pharmaceuticals, Inc. (079391286)
Registrant - ScieGen Pharmaceuticals, Inc. (079391286)
Establishment
NameAddressID/FEIOperations
ScieGen Pharmaceuticals, Inc.079391286ANALYSIS(50228-201, 50228-202), MANUFACTURE(50228-201, 50228-202), PACK(50228-201, 50228-202), LABEL(50228-201, 50228-202)

Revised: 03/2016
 
ScieGen Pharmaceuticals, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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