Allergy Relief by TOPCO ASSOCIATES LLC 1191A-TCR-2022-1118

Allergy Relief by

Drug Labeling and Warnings

Allergy Relief by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALLERGY RELIEF- fexofenadine hydrochloride tablet 
TOPCO ASSOCIATES LLC

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1191A-TCR-2022-1118

Drug Facts

Active ingredient (in each tablet)

Fexofenadine HCl 60 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other 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 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 60 mg tablet with water every 12 hours; do not take more than 2 tablets 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

• store between 20-25°C (68-77°F)
• protect from excessive moisture
• retain carton for complete product information and warnings

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide

PRINCIPAL DISPLAY PANEL

TopCare® health

NDC: 36800-761-02

COMPARE TO ALLEGRA® ALLERGY 12 HOUR ACTIVE INGREDIENT*

NON-DROWSY

Allergy Relief

FEXOFENADINE HYDROCHLORIDE TABLETS,

60 mg (ANTIHISTAMINE)

INDOOR/OUTDOOR ALLERGY RELIEF

12HR

Sneezing Runny Nose

Itchy, Watery Eyes

Itchy Nose or Throat

12 TABLETS

actual size

ALLERGY RELIEF 
fexofenadine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-761
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	60 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange ((PEACH))	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	G5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-761-02	1 in 1 PACKAGE	09/30/2021	10/31/2024
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211075	09/30/2021	10/31/2024

Labeler - TOPCO ASSOCIATES LLC (006935977)

Revised: 12/2025

Document Id: 458c2a39-cd75-2c60-e063-6394a90a1edc

34390-5

Set id: cb19fce3-1ee7-9f42-e053-2a95a90ac272

Version: 3

Effective Time: 20251209