BASIC CARE ALLERGY- fexofenadine hcl tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)
Available from:
L. Perrigo Company
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
Authorization status:
Abbreviated New Drug Application
Authorization number:
0113-7425-53, 0113-7425-78

BASIC CARE ALLERGY- fexofenadine hcl tablet, film coated

L. Perrigo Company

----------

Amazon Allergy Drug Facts

Active ingredient (in each tablet)

Fexofenadine HCl 60 mg

Purpos e

Antihistamine

Us es

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 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 (1-800-222-1222).

Directions

adults and children 12 years of age and take one 60 mg tablet with water every 12 hours; do not take

runny nose

itchy, watery eyes

sneezing

itching of the nose or throat

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)

over

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

Other information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron

oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene

glycol, povidone, titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Allegra

Allergy 12 HR active ingredient

NON-DROWSY

allergy

Fexofenadine Hydrochloride Tablets, 60 mg /Antihistamine

12 HR

actual size

INDOOR/OUTDOOR ALLERGY RELIEF

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Nose or Throat

12 TABLETS

do not use if printed blister unit is broken or torn

store between 20 -25 C (68 -77 F)

protect from excessive moisture

this product meets the requirements of USP Dissolution Test 3

BASIC CARE ALLERGY

fexofenadine hcl tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 113-7425

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

FEXO FENADINE HYDRO CHLO RIDE (UNII: 2S0 6 8 B75ZU) (FEXOFENADINE -

UNII:E6 58 2LOH6 V)

FEXOFENADINE

HYDROCHLORIDE

6 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

ORANGE (Peach)

S core

no sco re

S hap e

ROUND

S iz e

8 mm

Flavor

Imprint Code

9 3;7252

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 113-7425-53

12 in 1 CARTON

0 4/10 /20 19

1

1 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:0 113-7425-78

1 in 1 CARTON

0 4/10 /20 19

2

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

L. Perrigo Company

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 76 447

0 4/10 /20 19

Labeler -

L. Perrigo Company (006013346)

Revised: 11/2019

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