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NDC 11673-0617-01 up and up allergy relief 180 mg/1 Details

up and up allergy relief 180 mg/1

up and up allergy relief is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Target Corporation. 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: 11673-0617-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fexofenadine

Product Information

NDC	11673-0617
Product ID	11673-617_642da0b5-69e6-4219-ae21-a5443b5fba2c
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	up and up allergy relief
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	Target Corporation
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 11673-0617-01 (11673061701)

Pricing Information	N/A
NDC Package Code	11673-617-01
Billing NDC	11673061701
Package	1 BOTTLE in 1 CARTON (11673-617-01) / 70 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date	2021-09-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4f72589d-57e7-4c61-b29c-80636f0bd220 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 blister unit is broken or torn
•: 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?

Call 1-888-547-7400

Package/Label Principal Display Panel

Compare to active ingredient in Allegra® Allergy

non-drowsy

allergy relief

fexofenadine hydrochloride tablets 180 mg/antihistamine

indoor/outdoor allergy relief

• sneezing

• runny nose

• itchy, watery eyes

• itchy nose or throat

ACTUAL SIZE

24 HOUR

15 TABLETS

INGREDIENTS AND APPEARANCE

UP AND UP ALLERGY RELIEF

fexofenadine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11673-617
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:11673-617-22	15 in 1 CARTON	09/30/2021
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:11673-617-39	1 in 1 CARTON	09/17/2021
2		30 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:11673-617-00	1 in 1 CARTON	09/30/2021
3		40 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:11673-617-01	1 in 1 CARTON	09/30/2021
4		70 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:11673-617-47	1 in 1 CARTON	09/30/2021
5		150 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA212971	09/17/2021

Labeler - Target Corporation (006961700)

Revised: 9/2021

Document Id: 642da0b5-69e6-4219-ae21-a5443b5fba2c

Set id: 4f72589d-57e7-4c61-b29c-80636f0bd220

Version: 2

Effective Time: 20210930