FEXOFENADINE HCL- fexofenadine hcl tablet, film coated 
ScieGen Pharmaceuticals, Inc.

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    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

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:

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

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

ScieGen Pharmaceuticals, Inc.

Package/Label Principal Display Panel

Fexofenadine Hydrochloride Tablets USP 60mg

ScieGen Pharmaceuticals, Inc.

Package/Label Principal Display Panel

Fexofenadine Hydrochloride Tablets USP 180mg

ScieGen Pharmaceuticals, Inc.

Package/Label Principal Display Panel

Fexofenadine Hydrochloride Tablets USP 180mg

ScieGen Pharmaceuticals, Inc.

Package/Label Principal Display Panel

Fexofenadine Hydrochloride Tablets USP 60mg

ScieGen Pharmaceuticals, Inc.

Package/Label Principal Display Panel

Fexofenadine Hydrochloride Tablets USP 60mg

ScieGen Pharmaceuticals, Inc.

Package/Label Principal Display Panel

Fexofenadine Hydrochloride Tablets USP 180mg

ScieGen Pharmaceuticals, Inc.

Package/Label Principal Display Panel

Fexofenadine Hydrochloride Tablets USP 180mg

ScieGen Pharmaceuticals, Inc.
FEXOFENADINE HCL 
fexofenadine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50228-201
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize12mm
FlavorImprint Code SG;201
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50228-201-0130 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2014
2NDC:50228-201-021000 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2014
3NDC:50228-201-0330 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2014
4NDC:50228-201-041000 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2014
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code SG;202
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50228-202-0130 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2014
2NDC:50228-202-021000 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2014
3NDC:50228-202-0330 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2014
4NDC:50228-202-041000 in 1 BOTTLE; Type 0: Not a Combination Product12/26/2014
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/FEIBusiness Operations
ScieGen Pharmaceuticals, Inc.079391286ANALYSIS(50228-201, 50228-202) , MANUFACTURE(50228-201, 50228-202) , PACK(50228-201, 50228-202) , LABEL(50228-201, 50228-202)

Revised: 1/2020
Document Id: 60d30a0f-a76f-4aa8-b4fc-0dd1f6e44675
Set id: b7e9477d-33d9-4463-b8a6-69af5f71ce35
Version: 6
Effective Time: 20200119
 
ScieGen Pharmaceuticals, Inc.