IAllergy Relief: Package Insert and Label Information

IALLERGY RELIEF- fexofenadine hydrochloride tablet, coated
Safeway, Inc.

Active ingredient (in each film-coated tablet)

Fexofenadine HCl USP 180 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • 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 disease. Your doctor should determine if you 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 (1-800-222-1222) right away

Directions

adults and children 12 years of age and over

take one 18 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

  • each tablet contains: sodium 8 mg
  • store between 20-25ºC (68-77ºF)
  • protect from excessive moisture
  • this product meets the requirements of USP Dissolution Test 2

Inactive ingredients

anhydrous lactose,colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, pregelatinized starch (maize), polyethylene glycol, red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide

Questions or comments?

call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO Allegra® Allergy 24 Hr active ingredient*

24 Hour | Original Prescription Strength

Allergy Relief

FEXOFENADINE HCI 180mg

Antihistamine Coated Caplets

  • Relief of Runny nose, sneezing, itchy nose or throat, itchy & watery eyes
  • For indoor and outdoor allergies
  • Non-drowsy

COATED CAPLETS**

(**Capsule-shaped tablets)

*This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 24 HR.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY:

BETTER LIVING BRANDS LLC

P.O. BOX, PLEASANT, CA 94566-0009

www.betterlivingbrandsLLC.com

Product Label

Fexofenadine HCl USP 180 mg
(click image for full-size original)

SIGNATURE CARE Allergy Relief

IALLERGY RELIEF
fexofenadine hcl tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-405
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
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
ANHYDROUS LACTOSE
STARCH, CORN
STEARIC ACID
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code SG;202
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21130-405-30 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
1 30 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the BOX (21130-405-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204507 02/28/2020
Labeler — Safeway, Inc. (009137209)

Revised: 05/2020 Safeway, Inc.

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