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NDC 00113-0847-22 good sense aller ease 180 mg/1 Details

good sense aller ease 180 mg/1

good sense aller ease is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by L. Perrigo Company. 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: 00113-0847-22
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fexofenadine

Product Information

NDC	00113-0847
Product ID	0113-0847_e533a008-b437-401e-ab50-bda31e6662d3
Associated GPIs
GCN Sequence Number	033716
GCN Sequence Number Description	fexofenadine HCl TABLET 180 MG ORAL
HIC3	Z2Q
HIC3 Description	ANTIHISTAMINES - 2ND GENERATION
GCN	46594
HICL Sequence Number	011595
HICL Sequence Number Description	FEXOFENADINE HCL
Brand/Generic	Generic
Proprietary Name	good sense aller ease
Proprietary Name Suffix	n/a
Non-Proprietary Name	fexofenadine hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	180
Active Ingredient Units	mg/1
Substance Name	FEXOFENADINE HYDROCHLORIDE
Labeler Name	L. Perrigo Company
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA212971
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00113-0847-22 (00113084722)

Pricing Information	N/A
NDC Package Code	0113-0847-22
Billing NDC	00113084722
Package	15 BLISTER PACK in 1 CARTON (0113-0847-22) / 1 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date	2021-09-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e533a008-b437-401e-ab50-bda31e6662d3 Details

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
•: 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 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

•: do not use if printed foil under cap is broken or missing
•: store between 20° -25°C (68° -77°F)
•: protect from excessive moisture
•: this product meets the requirements of USP Dissolution Test 2

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Allergy

Aller • Ease

Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine

INDOOR/OUTDOOR

ALLERGY RELIEF

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Nose or Throat

Actual Size

NON-DROWSY

24 HR

Compare to active ingredient of Allegra® Allergy 24 HR

30 Tablets

INGREDIENTS AND APPEARANCE

GOOD SENSE ALLER EASE

fexofenadine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0113-0847
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)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	L847
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0113-0847-39	1 in 1 CARTON	09/10/2021
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:0113-0847-95	1 in 1 CARTON	09/14/2021
2		45 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:0113-0847-22	15 in 1 CARTON	09/14/2021
3		1 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	ANDA212971	09/10/2021

Labeler - L. Perrigo Company (006013346)

Revised: 9/2021

Document Id: e533a008-b437-401e-ab50-bda31e6662d3

Set id: e533a008-b437-401e-ab50-bda31e6662d3

Version: 1

Effective Time: 20210914