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
(click image for full-size original)

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.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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