Yyba (as Pld) - Welmate Antihistamine Allergy Relief (73581-011)

Yyba (as Pld) - Welmate Antihistamine Allergy Relief (73581-011)
SPL v18
SPL
SPL Set ID 2dd5e6b0-2445-4419-b0e6-c62aadee6ea4
Route
ORAL
Published
Effective Date 2025-01-02
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 Hypromellose, Unspecified Lactose Monohydrate Polyethylene Glycol, Unspecified Corn Ferric Oxide Red Stearic Acid 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 2021-03-25

Description

Fexofenadine HCl 180 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

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
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 51945-4

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.

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.

If pregnant or breast-feeding, ask a health professional before use.

Directions
 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 tablets in 24 hours
 children under 12 years of age  do not use
 adults 65 years and older  ask a doctor
 consumers with kidney disease  ask a doctor

Questions?

call toll-free 1-800-935-6737

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
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, yellow iron oxide.

Active Ingredient (in Each Tablet)

Fexofenadine HCl 180 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
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 51945-4 (51945-4)

Purpose

Antihistamine

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.

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.

If pregnant or breast-feeding, ask a health professional before use.

Directions
 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 tablets in 24 hours
 children under 12 years of age  do not use
 adults 65 years and older  ask a doctor
 consumers with kidney disease  ask a doctor

Questions?

call toll-free 1-800-935-6737

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
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, yellow iron oxide.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Fexofenadine HCl 180 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)