Fexofenadine Hcl Tablets Usp, 60 Mg And 180 Mg

SPL v1

SPL

SPL Set ID 1d46555d-827b-b154-e063-6294a90ad3d5

Route

ORAL

Published

Effective Date 2024-07-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fexofenadine (180 mg)

Inactive Ingredients

Propylene Glycol Gelatin Hydroxypropyl Cellulose (90000 Wamw) Croscarmellose Sodium Ferrosoferric Oxide Fd&c Blue No. 1 Fd&c Yellow No. 6 Hypromellose 2910 (3 Mpa.s) Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol 8000 Silicon Dioxide Starch, Corn Titanium Dioxide Shellac D&c Red No. 33 Ammonia

Identifiers & Packaging

Pill Appearance

Imprint: G18 Shape: oval Color: gray Size: 20 mm Score: 1

Marketing Status

ANDA Active Since 2024-01-02

Description

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCl USP, 180 mg

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

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

Do Not Use

if you have ever had an allergic reaction to this product or any of its ingredients.

Other Information

safety sealed: do not use if carton is opened or if individual blister units are torn or opened
store between 20º and 25ºC (68º and 77ºF)
protect from excessive moisture

Inactive Ingredients

ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, D & C Red 33, ferrosoferric oxide, FD & C blue 1, FD & C yellow 6, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, propylene glycol, shellac, titanium dioxide.

Questions Or Comments?

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

Manufactured By:

Granules India Limited

Hyderabad-500 081, India

MADE IN INDIA

Distributed By:

Granules USA, Inc.

Parsippany, NJ 07054

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.

Active Ingredient (in Each Tablet)

Fexofenadine HCl USP, 180 mg

Ask A Doctor Before Use If You Have

kidney disease. Your doctor should determine if you need a different dose.

Principal Display Panel 180 Mg Blister Foil

NDC 62207-623-71

Fexofenadine HCl

Tablet USP, 180 mg

Allergy

Antihistamine (GELCAP)

Mfg. by: Granules India Limited

Made in India

M.L.No.: 37/RR/AP/2003/F/R 24 HR

Push tablet through foil

LOT#

EXP. DATE:

Principal Display Panel 180 Mg Blister Carton

NDC 62207-623-71

NON-DROWSY

Fexofenadine HCl Tablets USP, 180 mg

Allergy

Antihistamine

INDOOR / OUTDOOR ALLERGY

RELIEF 24 HR

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat

70 (7x10) GELCAPS

Gel Coated Tablets

*Compare to the active ingredient in ALLEGRA ^® ALLERGY 24 HOUR

Principal Display Panel 180 Mg 24s Container Label

NDC 62207-623-41

NON-DROWSY

Fexofenadine HCl

Tablets USP, 180 mg

Allergy

Antihistamine

INDOOR / OUTDOOR ALLERGY

RELIEF 24HR

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat

24 GELCAPS

Gel Coated Tablets

*Compare to the active ingredient in

Allegra ^® Allergy 24 HOUR

Principal Display Panel 180 Mg 24s Container Carton

NDC 62207-623-41

NON-DROWSY

Fexofenadine HCl

Tablets, USP

180 mg

Allergy

Antihistamine

INDOOR / OUTDOOR ALLERGY

RELIEF 24 HR

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat

24 GELCAPS

Gel Coated Tablets

*Compare to the active ingredient in Allegra ^®

Allergy 24 HOUR

Structured Label Content

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

Purpose

Antihistamine

Warnings

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

Do Not Use (Do not use)

if you have ever had an allergic reaction to this product or any of its ingredients.

Other Information (Other information)

safety sealed: do not use if carton is opened or if individual blister units are torn or opened
store between 20º and 25ºC (68º and 77ºF)
protect from excessive moisture

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

Manufactured By:

Granules India Limited

Hyderabad-500 081, India

MADE IN INDIA

Distributed By:

Granules USA, Inc.

Parsippany, NJ 07054

When Using This Product (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 (Stop use and ask a doctor if)

an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Fexofenadine HCl USP, 180 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

kidney disease. Your doctor should determine if you need a different dose.

Principal Display Panel 180 Mg Blister Foil (PRINCIPAL DISPLAY PANEL 180 mg - Blister Foil)

NDC 62207-623-71

Fexofenadine HCl

Tablet USP, 180 mg

Allergy

Antihistamine (GELCAP)

Mfg. by: Granules India Limited

Made in India

M.L.No.: 37/RR/AP/2003/F/R 24 HR

Push tablet through foil

LOT#

EXP. DATE:

Principal Display Panel 180 Mg Blister Carton (PRINCIPAL DISPLAY PANEL 180 mg - Blister Carton)

NDC 62207-623-71

NON-DROWSY

Fexofenadine HCl Tablets USP, 180 mg

Allergy

Antihistamine

INDOOR / OUTDOOR ALLERGY

RELIEF 24 HR

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat

70 (7x10) GELCAPS

Gel Coated Tablets

*Compare to the active ingredient in ALLEGRA ^® ALLERGY 24 HOUR

Principal Display Panel 180 Mg 24s Container Label (PRINCIPAL DISPLAY PANEL 180 mg - 24s Container Label)

NDC 62207-623-41

NON-DROWSY

Fexofenadine HCl

Tablets USP, 180 mg

Allergy

Antihistamine

INDOOR / OUTDOOR ALLERGY

RELIEF 24HR

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat

24 GELCAPS

Gel Coated Tablets

*Compare to the active ingredient in

Allegra ^® Allergy 24 HOUR

Principal Display Panel 180 Mg 24s Container Carton (PRINCIPAL DISPLAY PANEL 180 mg -24s Container Carton)

NDC 62207-623-41

NON-DROWSY

Fexofenadine HCl

Tablets, USP

180 mg

Allergy

Antihistamine

INDOOR / OUTDOOR ALLERGY

RELIEF 24 HR

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat

24 GELCAPS

Gel Coated Tablets

*Compare to the active ingredient in Allegra ^®

Allergy 24 HOUR

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "Purpose": "Antihistamine", "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", "Do not use": "if you have ever had an allergic reaction to this product or any of its ingredients.", "Other information": "safety sealed: do not use if carton is opened or if individual blister units are torn or opened store between 20º and 25ºC (68º and 77ºF) protect from excessive moisture", "Inactive ingredients": "ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, D & C Red 33, ferrosoferric oxide, FD & C blue 1, FD & C yellow 6, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, propylene glycol, shellac, titanium dioxide.", "Questions or comments?": "Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST. Manufactured By: Granules India Limited Hyderabad-500 081, India MADE IN INDIA Distributed By: Granules USA, Inc. Parsippany, NJ 07054", "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.", "Active ingredient (in each tablet)": "Fexofenadine HCl USP, 180 mg", "Ask a doctor before use if you have": "kidney disease. Your doctor should determine if you need a different dose.", "PRINCIPAL DISPLAY PANEL 180 mg - Blister Foil": "NDC 62207-623-71 Fexofenadine HCl Tablet USP, 180 mg Allergy Antihistamine (GELCAP) Mfg. by: Granules India Limited Made in India M.L.No.: 37/RR/AP/2003/F/R 24 HR Push tablet through foil LOT# EXP. DATE:", "PRINCIPAL DISPLAY PANEL 180 mg - Blister Carton": "NDC 62207-623-71 NON-DROWSY Fexofenadine HCl Tablets USP, 180 mg Allergy Antihistamine INDOOR / OUTDOOR ALLERGY RELIEF 24 HR Sneezing Runny Nose Itchy, Watery Eyes Itchy Nose or Throat 70 (7x10) GELCAPS Gel Coated Tablets *Compare to the active ingredient in ALLEGRA ® ALLERGY 24 HOUR", "PRINCIPAL DISPLAY PANEL 180 mg - 24s Container Label": "NDC 62207-623-41 NON-DROWSY Fexofenadine HCl Tablets USP, 180 mg Allergy Antihistamine INDOOR / OUTDOOR ALLERGY RELIEF 24HR Sneezing Runny Nose Itchy, Watery Eyes Itchy Nose or Throat 24 GELCAPS Gel Coated Tablets *Compare to the active ingredient in Allegra ® Allergy 24 HOUR", "PRINCIPAL DISPLAY PANEL 180 mg -24s Container Carton": "NDC 62207-623-41 NON-DROWSY Fexofenadine HCl Tablets, USP 180 mg Allergy Antihistamine INDOOR / OUTDOOR ALLERGY RELIEF 24 HR Sneezing Runny Nose Itchy, Watery Eyes Itchy Nose or Throat 24 GELCAPS Gel Coated Tablets *Compare to the active ingredient in Allegra ® Allergy 24 HOUR"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:24.115414 · Updated: 2026-03-14T23:03:27.182760