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NDC 36800-0652-16 Allergy Relief 180 mg/1 Details

Allergy Relief 180 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.

MedlinePlus Drug Summary

Fexofenadine is used to relieve the allergy symptoms of seasonal allergic rhinitis (''hay fever''), including runny nose; sneezing; red, itchy, or watery eyes; or itching of the nose, throat, or roof of the mouth in adults and children 2 years of age and older. It is also used to relieve symptoms of urticaria (hives; red, itchy raised areas of the skin), including itching and rash in adults and children 6 months of age and older. Fexofenadine is in a class of medications called antihistamines. It works by blocking the effects of histamine, a substance in the body that causes allergy symptoms.

Related Packages: 36800-0652-16
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fexofenadine

Product Information

NDC	36800-0652
Product ID	36800-652_d0e84032-1758-4467-e053-2a95a90a2d74
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	180
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	ANDA204507
Listing Certified Through	n/a

Package

Package Images

NDC 36800-0652-16 (36800065216)

Pricing Information	N/A
NDC Package Code	36800-652-16
Billing NDC	36800065216
Package	2 BOTTLE, PLASTIC in 1 CARTON (36800-652-16) / 30 TABLET in 1 BOTTLE, PLASTIC
Marketing Start Date	2019-01-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7baac46a-de3b-287d-e053-2991aa0a999c Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Fexofenadine HCl 180 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 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 8.2 mg
store between 20-25°C (68-77°F)
protect from excessive moisture
this product meets the requirements of USP Dissolution Test 2
retain carton for complete product information and warnings

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

TopCare Health™

Compare to Allegra® Allergy Active Ingredient

NDC 36800-652-14

Non-Drowsy

Allergy Relief

Fexofenadine Hydrochloride Tablets,

180 mg (Antihistamine)

Indoor/Outdoor Allergy Relief

Sneezing
Runny Nose
Itchy, watery eyes
Itchy Nose or Throat

24 HR

180 Tablets

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF

fexofenadine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-652
Route of Administration	ORAL

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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-652-16	2 in 1 CARTON	01/29/2019	04/30/2023
1		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:36800-652-14	180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/29/2019	04/30/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA204507	05/12/2018	04/30/2023

Labeler - TopCo Associates LLC (006935977)

Revised: 11/2021

Document Id: d0e84032-1758-4467-e053-2a95a90a2d74

Set id: 7baac46a-de3b-287d-e053-2991aa0a999c

Version: 3

Effective Time: 20211116