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NDC 70518-2971-01 Fexofenadine hydrochloride 180 mg/1 Details

Fexofenadine hydrochloride 180 mg/1

Fexofenadine hydrochloride is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by REMEDYREPACK 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: 70518-2971-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fexofenadine

Product Information

NDC	70518-2971
Product ID	70518-2971_ed228e92-8f5a-7306-e053-2995a90adb7b
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	Fexofenadine hydrochloride
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	REMEDYREPACK INC.
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA076502
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70518-2971-01 (70518297101)

Pricing Information	N/A
NDC Package Code	70518-2971-1
Billing NDC	70518297101
Package	30 TABLET in 1 BOTTLE, PLASTIC (70518-2971-1)
Marketing Start Date	2022-04-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a82c6918-2fbf-4db8-b3d6-2efef28b3d49 Details

Active ingredient(s)

Fexofenadine HCl USP, 30 mg

Fexofenadine HCl USP, 60 mg

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Use(s)

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 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.

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

safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing
store between 20° and 25°C (68° and 77°F)
protect from excessive moisture
this product meets the requirements of USP Dissolution Test 4

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titanium dioxide

Questions?

Call 1-888-375-3784

PRINCIPAL DISPLAY PANEL

DRUG: Fexofenadine hydrochloride

GENERIC: Fexofenadine hydrochloride

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-2971-0

NDC: 70518-2971-1

COLOR: pink

SHAPE: OVAL

SCORE: No score

SIZE: 7 mm

IMPRINT: 194;R

PACKAGING: 100 in 1 BOTTLE, PLASTIC

PACKAGING: 30 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

Fexofenadine Hydrochloride 180mg in 1

INACTIVE INGREDIENT(S):

SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MANNITOL
POWDERED CELLULOSE
FD&C RED NO. 40
HYPROMELLOSE 2910 (6 MPA.S)
FERROSOFERRIC OXIDE
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
STARCH, CORN

INGREDIENTS AND APPEARANCE

FEXOFENADINE HYDROCHLORIDE

fexofenadine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70518-2971(NDC:55111-784)
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	7mm
Flavor		Imprint Code	194;R
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70518-2971-0	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/16/2020
2	NDC:70518-2971-1	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076502	12/16/2020

Labeler - REMEDYREPACK INC. (829572556)

Revised: 11/2022

Document Id: ed228e92-8f5a-7306-e053-2995a90adb7b

Set id: a82c6918-2fbf-4db8-b3d6-2efef28b3d49

Version: 7

Effective Time: 20221110