Yyba - Welmate Allergy Relief - Levocetrizine Dihydrochloride, 5 Mg (73581-201)

Yyba - Welmate Allergy Relief - Levocetrizine Dihydrochloride, 5 Mg (73581-201)
SPL v6
SPL
SPL Set ID 8ee69332-742d-4071-95df-84bc42e170e7
Route
ORAL
Published
Effective Date 2021-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levocetirizine (5 mg)
Inactive Ingredients
Silicon Dioxide Hypromellose, Unspecified Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polysorbate 80 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: LL;H Shape: oval Color: white Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2020-06-30 Until 2025-12-02

Description

LEVOCETIRIZINE DIHYDROCHLORIDE USP 5 MG

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

LEVOCETIRIZINE DIHYDROCHLORIDE USP 5 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 right away (1-800-222-1222).

Section 51945-4

Warnings

Do not use

  • if you have kidney disease
  • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine

Ask a doctor before use if you have

  • ever had trouble urinating or emptying your bladder

When using this product

  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • you have trouble urinating or emptying your bladder
  • an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use
Directions

ADULTS 65 YEARS OF AGE AND OLDER  

  • ASK A DOCTOR

ADULTS AND CHILDREN 12-64 YEARS OF AGE

  • take 1 tablet (5 mg) once daily in the evening
  • do not take more than 1 tablet (5 mg) in 24 hours
  • ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms

CHILDREN 6-11 YEARS OF AGE

  • take ½ tablet (2.5 mg) once daily in the evening
  • do not take more than ½ tablet (2.5 mg) in 24 hours

CHILDREN UNDER 6 YEARS OF AGE

  • DO NOT USE

CONSUMERS WITH KIDNEY DISEASE

  • DO NOT USE
Questions?

CALL 1-866-933-6337

Other Information
  • store between 20-25°C (68-77°F)
  • safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing
Inactive Ingredients

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Active Ingredient (in Each Tablet)

LEVOCETIRIZINE DIHYDROCHLORIDE USP 5 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 right away (1-800-222-1222).

Section 51945-4 (51945-4)

Purpose

Antihistamine

Warnings

Do not use

  • if you have kidney disease
  • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine

Ask a doctor before use if you have

  • ever had trouble urinating or emptying your bladder

When using this product

  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • you have trouble urinating or emptying your bladder
  • an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use
Directions

ADULTS 65 YEARS OF AGE AND OLDER  

  • ASK A DOCTOR

ADULTS AND CHILDREN 12-64 YEARS OF AGE

  • take 1 tablet (5 mg) once daily in the evening
  • do not take more than 1 tablet (5 mg) in 24 hours
  • ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms

CHILDREN 6-11 YEARS OF AGE

  • take ½ tablet (2.5 mg) once daily in the evening
  • do not take more than ½ tablet (2.5 mg) in 24 hours

CHILDREN UNDER 6 YEARS OF AGE

  • DO NOT USE

CONSUMERS WITH KIDNEY DISEASE

  • DO NOT USE
Questions?

CALL 1-866-933-6337

Other Information (Other information)
  • store between 20-25°C (68-77°F)
  • safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

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

LEVOCETIRIZINE DIHYDROCHLORIDE USP 5 MG


Advanced Ingredient Data


Raw Label Data

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