topco associates llc. all day allergy drug facts

topco associates llc. all day allergy drug facts
SPL v4
SPL
SPL Set ID 393616df-52f1-4e77-b69c-8239ca193d5b
Route
oral
Published
Effective Date 2022-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
levocetirizine (5 mg)
Inactive Ingredients
hypromellose, unspecified lactose monohydrate magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: L9CZ;5 Shape: oval Color: white Size: 8 mm Score: 2
Marketing Status
anda active Since 2020-02-05

Purpose

Antihistamine

Description

Levocetirizine dihydrochloride 5 mg


Medication Information

Active Ingredient

Levocetirizine dihydrochloride 5 mg

Uses

temporarily relieves these symptoms due to hay fever or other respiratory allergies:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat
Purpose

Antihistamine

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
Other Information
  • store between 20° and 25°C (68° and 77°F)
  • do not use if blister unit is broken or torn
Inactive Ingredients

hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Description

Levocetirizine dihydrochloride 5 mg

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
Questions Or Comments?

1-888-423-0139

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
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).

Ask A Doctor Before Use If You Have
  • ever had trouble urinating or emptying your bladder
Package/label Principal Display Panel

TopCare® health

COMPARE TO XYZAL® ALLERGY 24HR ACTIVE INGREDIENT

ORIGINAL PRESCRIPTION STRENGTH

All Day Allergy

LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS, 5 mg

ANTIHISTAMINE

INDOOR & OUTDOOR ALLERGIES

24 HOUR

RELIEF OF:

• Sneezing • Runny Nose

• Itchy Nose or throat

• Itchy, Watery Eyes

10 TABLETS

actual size


Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Levocetirizine dihydrochloride 5 mg

Uses

temporarily relieves these symptoms due to hay fever or other respiratory allergies:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat
Purpose

Antihistamine

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
Other Information (Other information)
  • store between 20° and 25°C (68° and 77°F)
  • do not use if blister unit is broken or torn
Inactive Ingredients (Inactive ingredients)

hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Do Not Use (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
Questions Or Comments? (Questions or comments?)

1-888-423-0139

When Using This Product (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 (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 pregnant or breast-feeding:)
  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use
Keep Out of Reach of Children. (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).

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • ever had trouble urinating or emptying your bladder
Package/label Principal Display Panel (Package/Label Principal Display Panel)

TopCare® health

COMPARE TO XYZAL® ALLERGY 24HR ACTIVE INGREDIENT

ORIGINAL PRESCRIPTION STRENGTH

All Day Allergy

LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS, 5 mg

ANTIHISTAMINE

INDOOR & OUTDOOR ALLERGIES

24 HOUR

RELIEF OF:

• Sneezing • Runny Nose

• Itchy Nose or throat

• Itchy, Watery Eyes

10 TABLETS

actual size


Advanced Ingredient Data


Raw Label Data

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