Drug Facts

Drug Facts
SPL v104
SPL
SPL Set ID 7e4a2d02-c2b3-4a1f-8373-a0b0dec5ddea
Route
ORAL
Published
Effective Date 2026-03-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)
Inactive Ingredients
Lactose Monohydrate Magnesium Stearate Polyethylene Glycol, Unspecified Silicon Dioxide Croscarmellose Sodium Hypromellose, Unspecified Titanium Dioxide Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: G;4 Shape: oval Color: white Size: 9 mm Score: 2
Marketing Status
ANDA Active Since 2018-12-31
Description

Cetirizine HCl 10 mg

Purpose

Antihistamine

How Supplied

Cetirizine Hydrochloride 10mg Tablets NDC 71335-9733-1: 30 Tablets in a BOTTLE NDC 71335-9733-2: 14 Tablets in a BOTTLE NDC 71335-9733-3: 7 Tablets in a BOTTLE NDC 71335-9733-4: 10 Tablets in a BOTTLE NDC 71335-9733-5: 15 Tablets in a BOTTLE NDC 71335-9733-6: 90 Tablets in a BOTTLE NDC 71335-9733-7: 20 Tablets in a BOTTLE NDC 71335-9733-8: 60 Tablets in a BOTTLE NDC 71335-9733-9: 100 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504

Medication Information

Purpose

Antihistamine

How Supplied

Cetirizine Hydrochloride 10mg Tablets

  • NDC 71335-9733-1: 30 Tablets in a BOTTLE
  • NDC 71335-9733-2: 14 Tablets in a BOTTLE
  • NDC 71335-9733-3: 7 Tablets in a BOTTLE
  • NDC 71335-9733-4: 10 Tablets in a BOTTLE
  • NDC 71335-9733-5: 15 Tablets in a BOTTLE
  • NDC 71335-9733-6: 90 Tablets in a BOTTLE
  • NDC 71335-9733-7: 20 Tablets in a BOTTLE
  • NDC 71335-9733-8: 60 Tablets in a BOTTLE
  • NDC 71335-9733-9: 100 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack

Burbank, CA 91504

Description

Cetirizine HCl 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
Section 51945-4

Cetirizine Hydrochloride 10mg Tablets

Directions
adults and children 6 years and over  Take 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
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.

Other Information
  • store between 20º to 25ºC (68º to 77ºF)
  • contains no ingredient made from a gluten-containing grain(wheat, barley or rye)
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions Or Comments?

Call  1-888-588-1418 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the active ingredient in Zyrtec®

Allergy Relief

Cetirizine HCl Tablets USP, 10 mg/Antihistamine

Indoor & Outdoor Allergies

24 hour relief of

  • Sneezing 
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Original Prescription Strength

Tablets

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Zyrtec®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

Camber Consumer Care Inc, Piscataway, NJ 08854, USA

When Using This Product
  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • 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
Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each Tablet)

Cetirizine HCl 10 mg

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.

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 51945-4 (51945-4)

Cetirizine Hydrochloride 10mg Tablets

Purpose

Antihistamine

Directions
adults and children 6 years and over  Take 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
Do Not Use (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.

How Supplied (HOW SUPPLIED)

Cetirizine Hydrochloride 10mg Tablets

  • NDC 71335-9733-1: 30 Tablets in a BOTTLE
  • NDC 71335-9733-2: 14 Tablets in a BOTTLE
  • NDC 71335-9733-3: 7 Tablets in a BOTTLE
  • NDC 71335-9733-4: 10 Tablets in a BOTTLE
  • NDC 71335-9733-5: 15 Tablets in a BOTTLE
  • NDC 71335-9733-6: 90 Tablets in a BOTTLE
  • NDC 71335-9733-7: 20 Tablets in a BOTTLE
  • NDC 71335-9733-8: 60 Tablets in a BOTTLE
  • NDC 71335-9733-9: 100 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack

Burbank, CA 91504

Other Information
  • store between 20º to 25ºC (68º to 77ºF)
  • contains no ingredient made from a gluten-containing grain(wheat, barley or rye)
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call  1-888-588-1418 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the active ingredient in Zyrtec®

Allergy Relief

Cetirizine HCl Tablets USP, 10 mg/Antihistamine

Indoor & Outdoor Allergies

24 hour relief of

  • Sneezing 
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Original Prescription Strength

Tablets

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Zyrtec®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

Camber Consumer Care Inc, Piscataway, NJ 08854, USA

When Using This Product (When using this product)
  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If (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 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 (1-800-222-1222) right away.

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

Cetirizine HCl 10 mg

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking tranquilizers or sedatives.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-03-14T20:08:22.894902 · Updated: 2026-03-14T23:14:11.403934