fe67f0f1-c6f1-424e-8226-19176de79945

SPL v4
SPL
SPL Set ID fe67f0f1-c6f1-424e-8226-19176de79945
Route
oral
Published
Effective Date 2024-02-20
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 2014-12-26

Purpose

Antihistamine

Description

Fexofenadine HCl USP 60 mg


Medication Information

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
Purpose

Antihistamine

Other Information
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
  • each tablet contains:sodium 2.7mg(for 60 mg)
  • this product meets the requirements of USP Dissolution Test 2
  • Tamper Evident:Do not use if imprinted inner safety seal is torn or missing
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.

Description

Fexofenadine HCl USP 60 mg

Section 50565-1

Keep out of reach of children.

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

Section 51945-4

Section 53414-9

If pregnant or breast-feeding,

ask a health professional before use.

Do Not Use

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

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

Questions Or Comments?

Call toll-free 1-877-225-6999

Distributed by:

Akron Pharma, Inc.

Fairfield, NJ 07004

www.akronpharma.com

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.

                             Allergy

Fexofenadine HCl USP 60 mg


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
Purpose

Antihistamine

Other Information (Other information)
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
  • each tablet contains:sodium 2.7mg(for 60 mg)
  • this product meets the requirements of USP Dissolution Test 2
  • Tamper Evident:Do not use if imprinted inner safety seal is torn or missing
Inactive Ingredients (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.

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.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding,

ask a health professional before use.

Do Not Use (Do not use)

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

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

Questions Or Comments? (Questions or comments?)

Call toll-free 1-877-225-6999

Distributed by:

Akron Pharma, Inc.

Fairfield, NJ 07004

www.akronpharma.com

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.

                             Allergy (                             ALLERGY)

Fexofenadine HCl USP 60 mg


Advanced Ingredient Data


Raw Label Data

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