Fexofenadine Hydrochloride Tablets, 180 mg

Set ID
5307b7ef-0c22-4aae-a2f6-033d31032f55
Manufacturer
SPIRIT PHARMACEUTICALS LLC
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:43:12

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each caplet)

Fexofenadine HCl USP 180 mg

Purpose

Antihistamine

Uses

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

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.

Stop use and ask a doctor if

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

If pregnant and breast-feeding,

ask a health professional before use.

Directions And Dosage

Directions

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

Other Label Information

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.

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Allegra® Allergy 24 Hour† ALLERGY RELIEF Fexofenadine HCl tablets USP 180 mg / antihistamine 100 TABLETS

Products

NDC Codes

Ingredients

NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
STARCH, CORNO8232NY3SJIACT
HYPROMELLOSES3NXW29V3WOIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
FERRIC OXIDE RED1K09F3G675IACT
STEARIC ACID4ELV7Z65APIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FEXOFENADINE HYDROCHLORIDE2S068B75ZUACTIB

Complete SPL Sections

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl USP 180 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

Do not use if

WARNINGS SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

When using this product

OTC - WHEN USING SECTION

■ 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

OTC - STOP USE SECTION

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

If pregnant and breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Allegra® Allergy 24 Hour† ALLERGY RELIEF Fexofenadine HCl tablets USP 180 mg / antihistamine 100 TABLETS

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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XML bytes
23260

Legacy File Index

FolderFileDate
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otc0bf31911-9c23-24fc-e063-6394a90a6386.xml2023-12-08
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otcb5f84df3-ced4-0c9c-e053-2995a90a4efe.xml2020-12-10
otca97830ec-1121-a64f-e053-2995a90aa5bd.xml2020-07-03
otcFEXO 100 CT.jpg2020-07-03