ALLERGY RELIEF NON-DROWSY- fexofenadine hcl tablet, coated

Allergy Relief by

Drug Labeling and Warnings

Allergy Relief by is a Otc medication manufactured, distributed, or labeled by BJWC (Berkley & Jensen / BJ's). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 right away (1-800-222-1222).

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

• 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), stearic acid,  polyethylene glycol, red iron oxide, titanium dioxide, and yellow iron oxide

Questions or comments?

call toll free 1-800-934-1204 Monday- Friday 9AM- 5PM EST

Principal Display Panel

*Compare to the active ingredient in Allegra® Allergy 24 hour

Original Prescription Strength

NON-DROWSY

ALLERGY RELIEF

FEXOFENADINE HYDROCHLORIDE 180 mg

ANTIHISTAMINE

INDOOR & OUTDOOR ALLERGIES

24 HOUR RELIEF OF

• RUNNY NOSE
• SNEEZING
• ITCHY, WATERY EYES
• ITCHY NOSE OR THROAT

COATED CAPLETS**

(**CAPSULE-SHAPED TABLETS)

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

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: BJs Wholesale Club

25 Research Drive, Westborough, MA 01581

Product Label

BJs Non-Drowsy Allergy Relief

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF  NON-DROWSY
fexofenadine hcl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68391-504
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	180 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	PINK	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	SG;202
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68391-504-15	1 in 1 BOX	03/31/2018
1		150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA204507	03/31/2018

Labeler - BJWC (Berkley & Jensen / BJ's) (159082692)