Package/label Principal Display Panel

Package/label Principal Display Panel
SPL v3
SPL
SPL Set ID 93bdf7ff-4139-450e-a7bd-6c5a957b14ca
Route
ORAL
Published
Effective Date 2021-05-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Fexofenadine HCl 60 mg


Medication Information

Indications and Usage

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

Dosage and Administration

adults and children 12 years of age and over take one 60 mg 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

Description

Fexofenadine HCl 60 mg

Section 44425-7

• do not use if printed blister unit is broken or torn • store between 20 ° -25 ° C (68 ° -77 ° F) • protect from excessive moisture • this product meets the requirements of USP Dissolution Test 3

Section 50565-1

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

Section 50566-9

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

Section 50567-7

• 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)

Section 50569-3

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

Section 50570-1

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

Section 51727-6

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

Section 51945-4

12 HR Compare to the active ingredient of Allegra® Allergy NON-DROWSY ALLERGY RELIEF FEXOFENADINE HYDROCHLORIDE TABLETS, 60 mg ANTIHISTAMINE INDOOR/OUTDOOR ALLERGY RELIEF OF • Sneezing • Runny nose • Itchy, watery eyes & Itchy nose or throat ACTUAL SIZE 24 TABLETS

Section 53413-1

1-800-719-9260

Section 53414-9

ask a health professional before use.

Section 55105-1

Antihistamine

Section 55106-9

Fexofenadine HCl 60 mg


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

adults and children 12 years of age and over take one 60 mg 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

Section 44425-7 (44425-7)

• do not use if printed blister unit is broken or torn • store between 20 ° -25 ° C (68 ° -77 ° F) • protect from excessive moisture • this product meets the requirements of USP Dissolution Test 3

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

• 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)

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

Section 51945-4 (51945-4)

12 HR Compare to the active ingredient of Allegra® Allergy NON-DROWSY ALLERGY RELIEF FEXOFENADINE HYDROCHLORIDE TABLETS, 60 mg ANTIHISTAMINE INDOOR/OUTDOOR ALLERGY RELIEF OF • Sneezing • Runny nose • Itchy, watery eyes & Itchy nose or throat ACTUAL SIZE 24 TABLETS

Section 53413-1 (53413-1)

1-800-719-9260

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Antihistamine

Section 55106-9 (55106-9)

Fexofenadine HCl 60 mg


Raw Label Data

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