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NDC 63868-0334-30 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 CHAIN DRUG MARKETING ASSOCIATION INC. 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: 63868-0334-30
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fexofenadine

Product Information

NDC	63868-0334
Product ID	63868-334_cb698988-2d8c-e15d-e053-2a95a90a5ec4
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	CHAIN DRUG MARKETING ASSOCIATION INC
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 63868-0334-30 (63868033430)

Pricing Information	N/A
NDC Package Code	63868-334-30
Billing NDC	63868033430
Package	1 BOTTLE, PLASTIC in 1 CARTON (63868-334-30) / 30 TABLET in 1 BOTTLE, PLASTIC
Marketing Start Date	2021-07-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c5d58d74-da08-eb72-e053-2a95a90adc27 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

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 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

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

QUALITY CHOICE®

NDC 63868-334-30

*Compare to the Active Ingredient in ALLEGRA® Allergy 24 Hour

Non-Drowsy

Allergy Relief

Fexofenadine Hydrochloride Tablets, 180mg | Antihistamine

Indoor / Outdoor Allergies

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Nose or Throat

24 Hour

actual size

30 TABLETS

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF

fexofenadine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-334
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
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 (Capsule-shaped)	Size	17mm
Flavor		Imprint Code	G6
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63868-334-15	3 in 1 CARTON	07/06/2021
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:63868-334-30	1 in 1 CARTON	07/06/2021
2		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:63868-334-45	1 in 1 BOTTLE, PLASTIC	07/06/2021
3		45 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA211075	07/06/2021

Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)

Revised: 9/2021

Document Id: cb698988-2d8c-e15d-e053-2a95a90a5ec4

Set id: c5d58d74-da08-eb72-e053-2a95a90adc27

Version: 3

Effective Time: 20210907

Search by Drug Name or NDC

NDC 63868-0334-30 Allergy Relief 180 mg/1 Details

Allergy Relief 180 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 63868-0334-30 (63868033430)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL c5d58d74-da08-eb72-e053-2a95a90adc27 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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