Fexofenadine Hcl Tablets Usp

SPL v3

SPL

SPL Set ID 3c30a1dc-a13d-2522-d4d0-00c1e9dbab07

Route

ORAL

Published

Effective Date 2014-01-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fexofenadine (180 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

ANDA Active Since 2013-04-22

Description

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Medication Information

Warnings and Precautions

Purpose

Antihistamine

Description

Fexofenadine HCl USP, 180 mg

Use(s)

Allergy

temporarily relieves these symptoms due to hay fever or otherupper respiratory allergies:

runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

Hives

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occuring.

Storage

store between 20° - 25°C (68° - 77°F)

protect from excessive moisture

this product meets the requirements of USP Dissolution Test 2.

Warnings

Hives

Severe Allergic Warning: Get emergency help immediately if you have hives along with any of the following symptom:

trouble swallowing
dizziness or loss of consciousness
swelling of tongue
swelling in or around mouth
trouble speaking
drooling
wheezing or problems breathing

These symptoms may be signs of anaphylactic shock. This condition canbe life threatening if not treated by a health professional immediately.Symptoms of anaphylactic shock may occur when hives first appear or upto a few hours later.

Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrineinjector for “anaphylaxis” or severe allergy symptoms that could occur withyour hives, never use this product as a substitute for the epinephrine injector.If you have been prescribed an epinephrine injector, you should carry it withyou at all times.

Directions

180 mg

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

Allergy

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

Hives

to prevent hives from any known cause such as:
- foods
- insect stings
- medicines
- latex or rubber gloves

because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

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

Containercarton

Container Carton Label: 30 count

Other Information

safety sealed: do not use if carton is opened or if individual blister units are torn or opened.

Active Ingredient(s)

Fexofenadine HCl USP, 180 mg

Inactive Ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, mannitol, and powdered cellulose, opadry pink 03B54504 containing FD&C Red no. 40, hypromellose, iron oxide black, polyethylene glycol and titanium dioxide.

Questions Or Comments?

call toll-free 1-888-375-3784

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally - 500 090 INDIA

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

Allergy

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

Hives

an allergic reaction to this product occurs. Seek medical help right away.
symptoms do not improve after 3 days of treatment
the hives have lasted more than 6 weeks

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.

Blister Carton Label: 15 Count

Blister Carton Label: 15 count

Ask A Doctor Before Use If You Have

Allergy

kidney disease. Your doctorshould determine if you need a different dose.

Hives

kidney disease. Your doctor should determine if you need a different dose.
hives that are an unusual color, look bruised or blistered
hives that do not itch

Structured Label Content

Use(s)

Allergy

temporarily relieves these symptoms due to hay fever or otherupper respiratory allergies:

runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

Hives

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occuring.

Warnings and Precautions (34071-1)

Purpose

Antihistamine

Storage

store between 20° - 25°C (68° - 77°F)

protect from excessive moisture

this product meets the requirements of USP Dissolution Test 2.

Warnings

Hives

Severe Allergic Warning: Get emergency help immediately if you have hives along with any of the following symptom:

trouble swallowing
dizziness or loss of consciousness
swelling of tongue
swelling in or around mouth
trouble speaking
drooling
wheezing or problems breathing

Directions

180 mg

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)

Allergy

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

Hives

to prevent hives from any known cause such as:
- foods
- insect stings
- medicines
- latex or rubber gloves

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

Containercarton (containercarton)

Container Carton Label: 30 count

Other Information (Other information)

safety sealed: do not use if carton is opened or if individual blister units are torn or opened.

Active Ingredient(s) (Active ingredient(s))

Fexofenadine HCl USP, 180 mg

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

call toll-free 1-888-375-3784

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally - 500 090 INDIA

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 Doctor If (Stop use and ask doctor if)

Allergy

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

Hives

an allergic reaction to this product occurs. Seek medical help right away.
symptoms do not improve after 3 days of treatment
the hives have lasted more than 6 weeks

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.

Blister Carton Label: 15 Count (Blister Carton Label: 15 count)

Blister Carton Label: 15 count

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

Allergy

kidney disease. Your doctorshould determine if you need a different dose.

Hives

kidney disease. Your doctor should determine if you need a different dose.
hives that are an unusual color, look bruised or blistered
hives that do not itch

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use(s)": "Allergy temporarily relieves these symptoms due to hay fever or otherupper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat Hives reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occuring.", "Purpose": "Antihistamine", "Storage": "store between 20° - 25°C (68° - 77°F) protect from excessive moisture this product meets the requirements of USP Dissolution Test 2.", "Warnings": "Hives Severe Allergic Warning: Get emergency help immediately if you have hives along with any of the following symptom: trouble swallowing dizziness or loss of consciousness swelling of tongue swelling in or around mouth trouble speaking drooling wheezing or problems breathing These symptoms may be signs of anaphylactic shock. This condition canbe life threatening if not treated by a health professional immediately .Symptoms of anaphylactic shock may occur when hives first appear or upto a few hours later. Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrineinjector for “anaphylaxis” or severe allergy symptoms that could occur withyour hives, never use this product as a substitute for the epinephrine injector.If you have been prescribed an epinephrine injector, you should carry it withyou at all times.", "Directions": "180 mg 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": "Allergy if you have ever had an allergic reaction to this product or any of its ingredients. Hives to prevent hives from any known cause such as: foods insect stings medicines latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. if you have ever had an allergic reaction to this product or any of its ingredients", "containercarton": "Container Carton Label: 30 count", "Other information": "safety sealed: do not use if carton is opened or if individual blister units are torn or opened.", "Active ingredient(s)": "Fexofenadine HCl USP, 180 mg", "Inactive ingredients": "colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, mannitol, and powdered cellulose, opadry pink 03B54504 containing FD&C Red no. 40, hypromellose, iron oxide black, polyethylene glycol and titanium dioxide.", "Questions or comments?": "call toll-free 1-888-375-3784 Manufactured by: Dr. Reddy’s Laboratories Limited Bachupally - 500 090 INDIA", "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": "Allergy an allergic reaction to this product occurs. Seek medical help right away. Hives an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve after 3 days of treatment the hives have lasted more than 6 weeks", "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.", "Blister Carton Label: 15 count": "Blister Carton Label: 15 count", "Ask a doctor before use if you have": "Allergy kidney disease. Your doctorshould determine if you need a different dose. Hives kidney disease. Your doctor should determine if you need a different dose. hives that are an unusual color, look bruised or blistered hives that do not itch"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:58.367911 · Updated: 2026-03-14T23:01:12.726296