INDOOR OUTDOOR ALLERGY RELIEF- fexofenadine hcl tablet, coated

Indoor Outdoor Allergy Relief by

Drug Labeling and Warnings

Indoor Outdoor Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Walgreens. 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 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

NON-DROWSY ORIGINAL PRESCRIPTION STRENGTH

Compare to the active ingredient in Allegra® Allergy 24 HR††

24 HOUR ALLERGY

FEXOFENADINE HCI 180mg / ANTIHISTAMINE

24 HOUR TABLETS

INDOOR & OUTDOOR ALLERGIES

• Relief of runny nose, sneezing, itchy, watery eyes & itchy nose or throat

COATED CAPLETS**

(**CAPSULES-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

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

Product Label

WALGREENS Indoor & Outdoor Allergies

INGREDIENTS AND APPEARANCE

INDOOR OUTDOOR ALLERGY RELIEF 
fexofenadine hcl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0904
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	WHITE	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: 0363-0904-15	15 in 1 CARTON	08/31/2018
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0363-0904-05	5 in 1 CARTON	08/31/2018
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 0363-0904-45	1 in 1 BOX	08/31/2018
3		45 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC: 0363-0904-70	1 in 1 BOX	08/31/2018
4		70 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5	NDC: 0363-0904-90	1 in 1 BOX	08/31/2018
5		90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6	NDC: 0363-0904-30	1 in 1 BOX	08/31/2018
6		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
7	NDC: 0363-0904-51	150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA204507	08/31/2018

Labeler - Walgreens (008965063)