Allergy Relief 24hr

Allergy Relief 24hr
SPL v6
SPL
SPL Set ID 8ba208dc-34fe-453a-8658-ed4f232e1a94
Route
ORAL
Published
Effective Date 2019-07-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levocetirizine (5 mg)
Inactive Ingredients
Hypromelloses Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol 400 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: X;X Shape: oval Color: white Size: 8 mm Score: 2
Marketing Status
ANDA Active Since 2019-07-02

Description

Allergy Relief 24HR Tablet Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Allergy Relief 24HR Tablet Drug Facts

Uses

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

  • runny nose

  • sneezing

  • itchy, watery eyes

  • itching of the nose or throat
Section 42229-5

Allergy Relief 24HR Tablet

Drug Facts

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

(Note: Age ranges are bolded in the draft container labeling for tablet bottle )

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
Active Ingredient

(in each tablet)

Levocetirizine dihydrochloride 5 mg

Other Information
  • store between 20° and 25°C (68° and 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 anhydrous silica, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, titanium dioxide

Questions Or Comments?

call 1-855-314 -1850

Principal Display Panel

Label for Allergy Relief 180 Tablets in a bottle

Label for Allergy Relief 10 Tablets in a bottle

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

Structured Label Content

Uses

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

  • runny nose

  • sneezing

  • itchy, watery eyes

  • itching of the nose or throat
Section 42229-5 (42229-5)

Allergy Relief 24HR Tablet

Drug Facts

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

(Note: Age ranges are bolded in the draft container labeling for tablet bottle )

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
Active Ingredient (Active ingredient)

(in each tablet)

Levocetirizine dihydrochloride 5 mg

Other Information (Other information)
  • store between 20° and 25°C (68° and 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 anhydrous silica, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, titanium dioxide

Questions Or Comments? (Questions or comments?)

call 1-855-314 -1850

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Label for Allergy Relief 180 Tablets in a bottle

Label for Allergy Relief 10 Tablets in a bottle

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)