Allergy Relief

Allergy Relief
SPL v13
SPL
SPL Set ID 652b0c65-a3f2-4454-9cf2-51a3389282cc
Route
ORAL
Published
Effective Date 2025-07-31
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (5 mg)
Inactive Ingredients
Lactose Monohydrate Starch, Corn Povidone K30 Magnesium Stearate Hypromellose, Unspecified Polyethylene Glycol, Unspecified Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 160 Shape: rectangle Shape: oval Color: white Size: 7 mm Size: 9 mm Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2025-04-10
Description

For 5 mg: Cetirizine HCl USP 5 mg For 10 mg: Cetirizine HCl USP 10 mg For 10 mg (Oval Shape): Cetirizine HCl USP 10 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

For 5 mg: Cetirizine HCl USP 5 mg For 10 mg: Cetirizine HCl USP 10 mg For 10 mg (Oval Shape): Cetirizine HCl USP 10 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
Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

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 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

For 5 mg:



adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours
adults 65 years and over 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.
children under 6 years of age ask a doctor 
consumers with liver or kidney disease ask a doctor  

 

For 10 mg:



adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours.  A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over ask a doctor
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor 


Other Information

•store between 20° to 25°C (68° to 77°F)

•do not use if foil seal under cap is broken or missing

Inactive Ingredients

corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide



Questions or comments? Call 1-877-376-4271

(weekdays 9 AM to 5 PM)

Principal Display Panel

NDC 25000-219-03

Cetirizine Hydrochloride Tablets USP, 5 mg

30s count bottle label





NDC 25000-219-03

Cetirizine Hydrochloride Tablets USP, 5 mg

30s count carton label





    

NDC 25000-219-08

Cetirizine Hydrochloride Tablets USP, 5 mg

100s count bottle label





NDC 25000-219-08

Cetirizine Hydrochloride Tablets USP, 5 mg

100s count carton label





NDC 25000-219-14 

Cetirizine Hydrochloride Tablets USP, 5 mg

1000s count bottle label  







NDC 25000-220-03

Cetirizine Hydrochloride Tablets USP, 10 mg

30s count bottle label

 



NDC 25000-220-03

Cetirizine Hydrochloride Tablets USP, 10 mg

30s count carton label







NDC 25000-220-08

Cetirizine Hydrochloride Tablets USP, 10 mg

100s count bottle label

 



NDC 25000-220-08

Cetirizine Hydrochloride Tablets USP, 10 mg

100s count carton label







NDC 25000-220-14

Cetirizine Hydrochloride Tablets USP, 10 mg

1000s count bottle label







NDC 25000-220-78

Cetirizine Hydrochloride Tablets USP, 10 mg

7s count carton label







NDC 25000-220-81

Cetirizine Hydrochloride Tablets USP, 10 mg

14s count carton label







NDC 25000-160-81

Cetirizine Hydrochloride Tablets USP, 10 mg (Oval Shape)

14s count carton label







NDC 25000-160-03

Cetirizine Hydrochloride Tablets USP, 10 mg (Oval Shape)

30s count carton label







NDC 25000-160-03 (Oval Shape)

Cetirizine Hydrochloride Tablets USP, 10 mg

30s count bottle label







NDC 25000-160-14

Cetirizine Hydrochloride Tablets USP, 10 mg (Oval Shape)

1000s count bottle label



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)

Active Ingredient (in Each Tablet)

For 5 mg:

Cetirizine HCl USP 5 mg



For 10 mg:

Cetirizine HCl USP 10 mg



For 10 mg (Oval Shape):

Cetirizine HCl USP 10 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
Purpose

Antihistamine

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

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 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

For 5 mg:



adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours
adults 65 years and over 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.
children under 6 years of age ask a doctor 
consumers with liver or kidney disease ask a doctor  

 

For 10 mg:



adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours.  A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over ask a doctor
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor 


Other Information (Other information)

•store between 20° to 25°C (68° to 77°F)

•do not use if foil seal under cap is broken or missing

Inactive Ingredients (Inactive ingredients)

corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide



Questions or comments? Call 1-877-376-4271

(weekdays 9 AM to 5 PM)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 25000-219-03

Cetirizine Hydrochloride Tablets USP, 5 mg

30s count bottle label





NDC 25000-219-03

Cetirizine Hydrochloride Tablets USP, 5 mg

30s count carton label





    

NDC 25000-219-08

Cetirizine Hydrochloride Tablets USP, 5 mg

100s count bottle label





NDC 25000-219-08

Cetirizine Hydrochloride Tablets USP, 5 mg

100s count carton label





NDC 25000-219-14 

Cetirizine Hydrochloride Tablets USP, 5 mg

1000s count bottle label  







NDC 25000-220-03

Cetirizine Hydrochloride Tablets USP, 10 mg

30s count bottle label

 



NDC 25000-220-03

Cetirizine Hydrochloride Tablets USP, 10 mg

30s count carton label







NDC 25000-220-08

Cetirizine Hydrochloride Tablets USP, 10 mg

100s count bottle label

 



NDC 25000-220-08

Cetirizine Hydrochloride Tablets USP, 10 mg

100s count carton label







NDC 25000-220-14

Cetirizine Hydrochloride Tablets USP, 10 mg

1000s count bottle label







NDC 25000-220-78

Cetirizine Hydrochloride Tablets USP, 10 mg

7s count carton label







NDC 25000-220-81

Cetirizine Hydrochloride Tablets USP, 10 mg

14s count carton label







NDC 25000-160-81

Cetirizine Hydrochloride Tablets USP, 10 mg (Oval Shape)

14s count carton label







NDC 25000-160-03

Cetirizine Hydrochloride Tablets USP, 10 mg (Oval Shape)

30s count carton label







NDC 25000-160-03 (Oval Shape)

Cetirizine Hydrochloride Tablets USP, 10 mg

30s count bottle label







NDC 25000-160-14

Cetirizine Hydrochloride Tablets USP, 10 mg (Oval Shape)

1000s count bottle label



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)

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

For 5 mg:

Cetirizine HCl USP 5 mg



For 10 mg:

Cetirizine HCl USP 10 mg



For 10 mg (Oval Shape):

Cetirizine HCl USP 10 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:39.861385 · Updated: 2026-03-14T23:09:33.254922