OTC Medication Information: Allegra Allergy

ALLEGRA ALLERGY- fexofenadine hydrochloride tablet, film coated
Navajo Manufacturing Company Inc.

Drug Facts

Active ingredient (in each tablet)

Fexofenadine HCl 180 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or 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 desease. Your doctor should determine ifyou 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

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

• ​safety sealed: do not use if individual blister is open or torn
• ​store between 20 ^​o and 25 ^​o C (68 ^​o ​ and 77 ^​o ​F)
• protect from excessive moisture

Inactive ingredients

colloidal silicone dioxide, croscarmellose sodium, hypromellose, iron oxide blends, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide

Questions or comments?

Call toll-free 1-800-633-1610 or www.allegra.com

Product Label

ALLEGRA ALLERGY fexofenadine hydrochloride tablet, film coated

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67751-033(NDC:41167-4120) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE 180 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE TITANIUM DIOXIDE

Product Characteristics Color orange (peach) Score no score Shape OVAL Size 17mm Flavor Imprint Code 018;E Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67751-033-01 1 TABLET, FILM COATED in 1 BLISTER PACK None 2 NDC:67751-033-02 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK 2 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (67751-033-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020872 05/12/2015

Labeler — Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Operations
Navajo Manufacturing Company Inc.		136941411	relabel (67751-033), repack (67751-033)

Revised: 03/2023 Navajo Manufacturing Company Inc.