451 - Allergy Relief 24hr

451 - Allergy Relief 24hr
SPL v3
SPL
SPL Set ID c523c210-b1c4-4049-9c72-2b31c9c93137
Route
ORAL
Published
Effective Date 2024-04-02
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: H;LL Shape: oval Color: white Size: 8 mm Score: 2
Marketing Status
ANDA Active Since 2024-04-02
Description

Levocetirizine dihydrochloride USP 5 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Levocetirizine dihydrochloride USP 5 mg

Use(s)

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

• runny nose

• sneezing

• itchy, watery eyes

• itching of the nose or throat

Directions
adults 65 years of age and older                               
  • ask a doctor
adults and children 12 to 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 to 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
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

Other Information
  • store at room temperature 20°– 25°C (68°– 77°F)
  • do not use if imprinted seal under safety cap is broken or missing
Questions/comments

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Active Ingredient(s)

Levocetirizine dihydrochloride USP 5 mg

Inactive Ingredients

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate,

microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Principal Display Panel
Allergy Relief 24HR
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
Ask A Doctor Before Use If
  • ever had trouble urinating or emptying your bladder
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 Breastfeeding,
  • 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).

Structured Label Content

Use(s)

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

• runny nose

• sneezing

• itchy, watery eyes

• itching of the nose or throat

Purpose

Antihistamine

Directions
adults 65 years of age and older                               
  • ask a doctor
adults and children 12 to 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 to 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
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

Other Information (Other information)
  • store at room temperature 20°– 25°C (68°– 77°F)
  • do not use if imprinted seal under safety cap is broken or missing
Questions/comments (Questions/Comments)

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Active Ingredient(s) (Active ingredient(s))

Levocetirizine dihydrochloride USP 5 mg

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate,

microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Principal Display Panel
Allergy Relief 24HR
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
Ask A Doctor Before Use If (Ask a doctor before use if)
  • ever had trouble urinating or emptying your bladder
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 Breastfeeding, (If pregnant or breastfeeding,)
  • 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).

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:41.625354 · Updated: 2026-03-14T23:07:53.934759