GOOD NEIGHBOR PHARMACY ALLERGY RELIEF- fexofenadine hydrochloride 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:
Amerisource Bergen
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:
46122-040-22, 46122-040-58, 46122-040-61, 46122-040-65, 46122-040-75

GOOD NEIGHBOR PHARMACY ALLERGY RELIEF- fexofenadine hydrochloride tablet, film

coated

Amerisource Bergen

----------

Amerisource Bergen Allergy Relief Drug Facts

Active ingredient (in each tablet)

Fexofenadine HCl 180 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

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)

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, 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 active ingredient

ORIGINAL PRESCRIPTION STRENGTH

Allergy Relief

fexofenadine hydrochloride tablets, 180 mg

Antihistamine

Relief of:

Sneezing - Runny Nose

Itchy, Watery Eyes - Itchy Nose or Throat

Indoor & Outdoor Allergies

24 HOUR

Non-Drowsy

30 tablets 180 mg EACH

actual size

do not use if printed foil under cap is broken or missing

store at 20°-25°C (68°-77°F)

protect from excessive moisture

this product meets the requirements of USP Dissolution Test 3

GOOD NEIGHBOR PHARMACY ALLERGY RELIEF

fexofenadine hydrochloride tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:46 122-0 40

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

18 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

12mm

Flavor

Imprint Code

9 3;7253

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:46 122-0 40 -22

15 in 1 CARTON

0 6 /22/20 11

10 /31/20 19

1

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

2

NDC:46 122-0 40 -6 1

1 in 1 CARTON

0 9 /0 8 /20 11

0 5/26 /20 19

2

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

3

NDC:46 122-0 40 -75

1 in 1 CARTON

10 /24/20 11

0 1/10 /20 19

3

9 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

4

NDC:46 122-0 40 -6 5

1 in 1 CARTON

0 9 /15/20 11

0 5/0 1/20 19

4

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

5

NDC:46 122-0 40 -58

1 in 1 CARTON

0 2/12/20 14

0 6 /11/20 17

5

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

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 6 /22/20 11

10 /31/20 19

Amerisource Bergen

Labeler -

Amerisource Bergen (007914906)

Revised: 4/2019

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