c067b335-79c5-4176-a0b3-bae02a0c23f8

SPL v1
SPL
SPL Set ID c067b335-79c5-4176-a0b3-bae02a0c23f8
Route
oral
Published
Effective Date 2024-09-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fexofenadine (180 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: SG202 Shape: oval Color: pink Size: 18 mm Score: 1
Marketing Status
anda active Since 2015-09-16

Purpose

Antihistamine

Description

Fexofenadine HCl 180 mg


Medication Information

Active Ingredient

Fexofenadine HCl 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
Purpose

Antihistamine

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 Information
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
  • each tablet contains:sodium 8.2 mg
  • this product meets the requirements of USP Dissolution Test 2
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
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 180 mg

Questions?

call toll free 1-800-630-8895

Section 42229-5

Distributed by:

Advanced Rx LLC

1942 NE 163rd St North Miami Beach,

FL 33162 U.S.A.

Section 50565-1

Keep out of reach of children.

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

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.

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.

Package/label Principal Display Panel

NDC 80513-506-01

Compare to the active ingredient in Allegra ®Allergy 24 Hour Tablets *

Non-Drowsy

Allergy Relief

Fexofenadine HCL 180 mg

INDOOR & OUTDOOR ALLERGY

24-Hour Allergy Relief Of:

  • Sneezing, runny nose
  • Itchy, watery eyes
  • Itchy throat or nose

100 Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Allegra ®Allergy 24 Hour Tablets.


Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Fexofenadine HCl 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
Purpose

Antihistamine

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 Information (Other information)
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
  • each tablet contains:sodium 8.2 mg
  • this product meets the requirements of USP Dissolution Test 2
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
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

Questions?

call toll free 1-800-630-8895

Section 42229-5 (42229-5)

Distributed by:

Advanced Rx LLC

1942 NE 163rd St North Miami Beach,

FL 33162 U.S.A.

Section 50565-1 (50565-1)

Keep out of reach of children.

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

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.

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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

NDC 80513-506-01

Compare to the active ingredient in Allegra ®Allergy 24 Hour Tablets *

Non-Drowsy

Allergy Relief

Fexofenadine HCL 180 mg

INDOOR & OUTDOOR ALLERGY

24-Hour Allergy Relief Of:

  • Sneezing, runny nose
  • Itchy, watery eyes
  • Itchy throat or nose

100 Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Allegra ®Allergy 24 Hour Tablets.


Advanced Ingredient Data


Raw Label Data

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