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NDC 36800-0761-02 Allergy Relief 60 mg/1 Details

Allergy Relief 60 mg/1

Allergy Relief is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by TOPCO ASSOCIATES LLC. The primary component is FEXOFENADINE HYDROCHLORIDE.

Product Information

NDC	36800-0761
Product ID	36800-761_ee29473d-92cb-d23a-e053-2a95a90a1343
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Allergy Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Fexofenadine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	60
Active Ingredient Units	mg/1
Substance Name	FEXOFENADINE HYDROCHLORIDE
Labeler Name	TOPCO ASSOCIATES LLC
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA211075
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0761-02 (36800076102)

Pricing Information	N/A
NDC Package Code	36800-761-02
Billing NDC	36800076102
Package	1 BLISTER PACK in 1 PACKAGE (36800-761-02) / 12 TABLET in 1 BLISTER PACK
Marketing Start Date	2021-09-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cb19fce3-1ee7-9f42-e053-2a95a90ac272 Details

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF

fexofenadine hydrochloride tablet

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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - TOPCO ASSOCIATES LLC (006935977)

Revised: 11/2022

Document Id: ee29473d-92cb-d23a-e053-2a95a90a1343

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

Version: 2

Effective Time: 20221123

Search by Drug Name or NDC

NDC 36800-0761-02 Allergy Relief 60 mg/1 Details

Allergy Relief 60 mg/1

Product Information

Package

Package Images

NDC 36800-0761-02 (36800076102)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL cb19fce3-1ee7-9f42-e053-2a95a90ac272 Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

Purpose

Uses

SPL UNCLASSIFIED SECTION

When using this product

Directions

Other information

Inactive ingredients

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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