FEXOFENADINE HYDROCHLORIDE - fexofenadine hydrochloride tablet, film coated 
Hetero Labs Limited

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Fexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg

ACTIVE INGREDIENT(S)

(in each tablet)
Fexofenadine Hydrochloride USP, 30 mg
Fexofenadine Hydrochloride USP, 60 mg
Fexofenadine Hydrochloride USP, 180 mg

PURPOSE

Antihistamine

USE(S)

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

STOP USE AND ASK DOCTOR IF

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

PREGNANCY/BREASTFEEDING

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

30 mg


adults and children 12 years of age and over
take two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in        24 hours
children 6 to under 12 years of age
take one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in              24 hours
children under 6 years of age
do not use
adults 65 years of age and older
ask a doctor
consumers with kidney disease
ask a doctor

60 mg


adults and children 12 years of age and over
take one 60 mg 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

180 mg


adults and children 12 years of age and over
take one 180 mg 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

Colloidal silicon dioxide, hypromellose, light liquid paraffin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.

QUESTIONS?

Call 1-866-495-1995

PRINCIPAL DISPLAY PANEL

Fexofenadine Hydrochloride Tablets USP, 30 mg - Container Carton


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Fexofenadine Hydrochloride Tablets USP, 30 mg - Container Label


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Fexofenadine Hydrochloride Tablets USP, 30 mg - Blister Foil


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Fexofenadine Hydrochloride Tablets USP, 30 mg - Blister Carton



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Fexofenadine Hydrochloride Tablets USP, 60 mg - Container Carton


Fexofenadine60mg30scarton






Fexofenadine Hydrochloride Tablets USP, 60 mg - Container Label


Fexofenadine60mg30slabel



Fexofenadine Hydrochloride Tablets USP, 60 mg - Blister Foil


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Fexofenadine Hydrochloride Tablets USP, 60 mg - Blister Carton


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Fexofenadine Hydrochloride Tablets USP, 180 mg - Container Carton


Fexofenadine180mg30scarton


Fexofenadine Hydrochloride Tablets USP, 180 mg - Container Label


Fexofendine180mg30slabel


Fexofenadine Hydrochloride Tablets USP, 180 mg - Blister Foil


Fexofendine180mg10sfoil


Fexofenadine Hydrochloride Tablets USP, 180 mg - Blister Carton


Fexofenadine180mg10scarton

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68554-5061
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorPINKScoreno score
ShapeROUND (biconvex) Size6mm
FlavorImprint Code j;42
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68554-5061-01 in 1 CARTON08/23/2016
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:68554-5061-11 in 1 CARTON08/23/2016
2100 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:68554-5061-21 in 1 CARTON08/23/2016
3500 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:68554-5061-510 in 1 CARTON08/23/2016
4NDC:68554-5061-410 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:68554-5061-622 in 1 CARTON08/23/2016
5NDC:68554-5061-310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20409708/23/2016
FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68554-5062
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorPINKScoreno score
ShapeOVAL (biconvex) Size12mm
FlavorImprint Code j;43
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68554-5062-01 in 1 CARTON08/23/2016
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:68554-5062-11 in 1 CARTON08/23/2016
2100 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:68554-5062-21 in 1 CARTON08/23/2016
3500 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:68554-5062-57 in 1 CARTON08/23/2016
4NDC:68554-5062-410 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:68554-5062-615 in 1 CARTON08/23/2016
5NDC:68554-5062-310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20409708/23/2016
FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68554-5063
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULE (biconvex) Size18mm
FlavorImprint Code j;44
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68554-5063-01 in 1 CARTON08/23/2016
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:68554-5063-11 in 1 CARTON08/23/2016
2100 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:68554-5063-21 in 1 CARTON08/23/2016
3500 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:68554-5063-57 in 1 CARTON08/23/2016
4NDC:68554-5063-410 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:68554-5063-615 in 1 CARTON08/23/2016
5NDC:68554-5063-310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20409708/23/2016
Labeler - Hetero Labs Limited (917261950)

Revised: 9/2016
Document Id: 12c87ec8-6af5-41bf-931a-8937e63cbad4
Set id: 412af925-12e9-405f-b3c3-d5c3d0b5d5c2
Version: 2
Effective Time: 20160908
 
Hetero Labs Limited