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SPL v104

SPL

SPL Set ID c23ad304-a5de-454e-a135-4eb143af2381

Route

ORAL

Published

Effective Date 2025-10-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fexofenadine (60 mg)

Inactive Ingredients

Anhydrous Lactose Silicon Dioxide Starch, Corn Croscarmellose Sodium Lactose Monohydrate Stearic Acid Hypromellose, Unspecified Polyethylene Glycol, Unspecified Ferric Oxide Red Titanium Dioxide Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance

Imprint: SG;201 Shape: oval Color: pink Size: 12 mm Score: 1

Marketing Status

ANDA Active Since 2021-08-26

Description

Fexofenadine HCl USP 60 mg Fexofenadine HCl USP 180 mg

Purpose

Antihistamine

How Supplied

Fexofenadine Hydrochloride 60mg Tablets NDC 71335-2165-1: 30 Tablets in a BOTTLE NDC 71335-2165-2: 10 Tablets in a BOTTLE NDC 71335-2165-3: 60 Tablets in a BOTTLE NDC 71335-2165-4: 90 Tablets in a BOTTLE NDC 71335-2165-5: 14 Tablets in a BOTTLE NDC 71335-2165-6: 20 Tablets in a BOTTLE NDC 71335-2165-7: 12 Tablets in a BOTTLE store between 20° and 25°C (68° and 77°F). protect from excessive moisture. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Medication Information

Purpose

Antihistamine

How Supplied

Fexofenadine Hydrochloride 60mg Tablets

NDC 71335-2165-1: 30 Tablets in a BOTTLE
NDC 71335-2165-2: 10 Tablets in a BOTTLE
NDC 71335-2165-3: 60 Tablets in a BOTTLE
NDC 71335-2165-4: 90 Tablets in a BOTTLE
NDC 71335-2165-5: 14 Tablets in a BOTTLE
NDC 71335-2165-6: 20 Tablets in a BOTTLE
NDC 71335-2165-7: 12 Tablets in a BOTTLE

store between 20° and 25°C (68° and 77°F). protect from excessive moisture.

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Description

Fexofenadine HCl USP 60 mg Fexofenadine HCl USP 180 mg

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

Section 50565-1

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).

Section 51945-4

Fexofenadine Hydrochloride 60mg Tablets

Section 53413-1

Questions or comments?

Call toll-free 1-888-588-1418

Monday-Friday 9AM-7PM EST

Distributed by: MAJOR ^®PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.majorpharmaceuticals.com

Section 53414-9

If pregnant or breast-feeding,

ask a health professional before use.

Allergy

Fexofenadine HCl USP 60 mg

Fexofenadine HCl USP 180 mg

Directions

Directions (for 60mg)

adults and children 12 years of age and over	take one 60mg tablet with water every 12 hours; do not take more than 2 tablets 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

Directions (for 180mg)

adults and children 12 years of age and over	take one 180mg 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

store between 20° and 25°C (68° and 77°F)
protect from excessive moisture
each tablet contains:sodium 2.7 mg (for 60 mg), sodium 8.2 mg (for 180 mg)
this product meets the requirements of USP Dissolution Test 2

Inactive Ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide

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.

Ask A Doctor Before Use If You Have

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

Structured Label Content

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

Section 50565-1 (50565-1)

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).

Section 51945-4 (51945-4)

Fexofenadine Hydrochloride 60mg Tablets

Section 53413-1 (53413-1)

Questions or comments?

Call toll-free 1-888-588-1418

Monday-Friday 9AM-7PM EST

Distributed by: MAJOR ^®PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.majorpharmaceuticals.com

Section 53414-9 (53414-9)

If pregnant or breast-feeding,

ask a health professional before use.

Allergy (ALLERGY)

Fexofenadine HCl USP 60 mg

Fexofenadine HCl USP 180 mg

Purpose

Antihistamine

Directions

Directions (for 60mg)

adults and children 12 years of age and over	take one 60mg tablet with water every 12 hours; do not take more than 2 tablets 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

Directions (for 180mg)

adults and children 12 years of age and over	take one 180mg 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.

How Supplied (HOW SUPPLIED)

Fexofenadine Hydrochloride 60mg Tablets

NDC 71335-2165-1: 30 Tablets in a BOTTLE
NDC 71335-2165-2: 10 Tablets in a BOTTLE
NDC 71335-2165-3: 60 Tablets in a BOTTLE
NDC 71335-2165-4: 90 Tablets in a BOTTLE
NDC 71335-2165-5: 14 Tablets in a BOTTLE
NDC 71335-2165-6: 20 Tablets in a BOTTLE
NDC 71335-2165-7: 12 Tablets in a BOTTLE

store between 20° and 25°C (68° and 77°F). protect from excessive moisture.

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Other Information (Other information)

store between 20° and 25°C (68° and 77°F)
protect from excessive moisture
each tablet contains:sodium 2.7 mg (for 60 mg), sodium 8.2 mg (for 180 mg)
this product meets the requirements of USP Dissolution Test 2

Inactive Ingredients (Inactive ingredients)

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.

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.

Advanced Ingredient Data

[{"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE YELLOW", "unii": "EX438O2MRT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FEXOFENADINE", "unii": "E6582LOH6V", "classCode": "ACTIB", "strengthNumerator": "60", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"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", "50565-1": "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).", "51945-4": "Fexofenadine Hydrochloride 60mg Tablets", "53413-1": "Questions or comments? Call toll-free 1-888-588-1418 Monday-Friday 9AM-7PM EST Distributed by: MAJOR ® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.majorpharmaceuticals.com", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "ALLERGY": "Fexofenadine HCl USP 60 mg Fexofenadine HCl USP 180 mg", "Purpose": "Antihistamine", "Directions": "Directions (for 60mg) adults and children 12 years of age and over take one 60mg tablet with water every 12 hours; do not take more than 2 tablets 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 Directions (for 180mg) adults and children 12 years of age and over take one 180mg 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.", "HOW SUPPLIED": "Fexofenadine Hydrochloride 60mg Tablets NDC 71335-2165-1: 30 Tablets in a BOTTLE NDC 71335-2165-2: 10 Tablets in a BOTTLE NDC 71335-2165-3: 60 Tablets in a BOTTLE NDC 71335-2165-4: 90 Tablets in a BOTTLE NDC 71335-2165-5: 14 Tablets in a BOTTLE NDC 71335-2165-6: 20 Tablets in a BOTTLE NDC 71335-2165-7: 12 Tablets in a BOTTLE store between 20° and 25°C (68° and 77°F). protect from excessive moisture. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504", "Other information": "store between 20° and 25°C (68° and 77°F) protect from excessive moisture each tablet contains: sodium 2.7 mg (for 60 mg), sodium 8.2 mg (for 180 mg) this product meets the requirements of USP Dissolution Test 2", "Inactive ingredients": "anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide", "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.", "Ask a doctor before use if you have": "kidney disease. Your doctor should determine if you need a different dose."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:37.387525 · Updated: 2026-03-14T23:13:11.905913