Cetirizine 10mg Tablets, Allergy Tablets DRUG FACTS

Manufacturer
Apotheca Inc.
Effective date
2010-04-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:24:11

Label at a glance#

ProductCETIRIZINE HYDROCHLORIDE
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure13 sections

Dosage and administration

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. 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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

(in each Tablet)
Cetirizine HCI 10mg

PURPOSE

OTC - PURPOSE SECTION

ANTIHISTAMINE
24 Hour Relief of Indoor and Outdoor Allergies

USES

OTC - PURPOSE SECTION

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

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

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

Ask a Doctor or Pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

if you are taking tranquilizers or sedatives.

When using this product

OTC - WHEN USING SECTION

  • drowsines may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinary.

Stop use and ask a doctor

OTC - STOP USE SECTION

if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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.
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 and inactive ingredients

INACTIVE INGREDIENT SECTION

Other information
  • store between 20° to 25°C (68° to 77°F)
Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin

Questions

OTC - QUESTIONS SECTION

Call 1-800-262-5244

Monday though Friday 9AM – 2PM MST

Distributed by:

RejuviLife, Phoenix, AZ

RejuviLife is a trademark of Apotheca Inc.

PACKAGE LABEL AND PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 12634-987-71
CETIRIZINE HCI
Antihistamine
Indoor and Outdoor Allergies

24 Hour Relief of Sneezing, Runny Nose, Itchy,
Watery Eyes, Itchy Throat or Nose.
Allergy Tablets
RejuviLife
30 Tablets
10 MG
image of label
image of label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN2
1014678cetirizine hydrochloride 10 MG Oral TabletSCD2
1014678cetirizine HCl 10 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CETIRIZINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-987-00CETIRIZINE HYDROCHLORIDE10 in 1 BOTTLE, PLASTICTABLET102
12634-987-01CETIRIZINE HYDROCHLORIDE100 in 1 BOTTLE, PLASTICTABLET1002
12634-987-50CETIRIZINE HYDROCHLORIDE50 in 1 BOTTLE, PLASTICTABLET502
12634-987-71CETIRIZINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET302
12634-987-80CETIRIZINE HYDROCHLORIDE20 in 1 BOTTLE, PLASTICTABLET202
12634-987-96CETIRIZINE HYDROCHLORIDE6 in 1 BOTTLE, PLASTICTABLET62
12634-987-97CETIRIZINE HYDROCHLORIDE7 in 1 BOTTLE, PLASTICTABLET72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-987CETIRIZINE HYDROCHLORIDE TABLET [APOTHECA INC.]2Legacy NDC, 7 package rows20100408_abaf61ad-17bd-4dcf-aff1-6687c4cb1b9f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12634-987-71EA - Each12634-987820f0d0e-bbef-4ee2-b5ae-c9b55277facc12015-10-02
0378-3637-01EA - Each0378-3637028bf28b-129a-44b3-b17f-3ec0cc8c05e512012-07-24
0378-3637-05EA - Each0378-36377b3d41e9-08e1-49ee-9c56-710b4d94508412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOA2
CETIRIZINEACTIVE MOIETYYO7261ME242
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U2
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WO2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076677-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-27
A076677-002CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2007-12-27
A076677-003CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2007-12-27
A076677-004CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A076677-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27c2088c7a36db…
2026-10-15 13:18:302026-09A076677-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27c2088c7a36db…
2026-10-15 13:18:302026-09A076677-003CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27c2088c7a36db…
2026-10-15 13:18:302026-09A076677-004CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27c2088c7a36db…
2026-09-14 22:38:342026-08A076677-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A076677-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A076677-003CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A076677-004CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-08-18 06:07:402026-07A076677-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A076677-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A076677-003CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A076677-004CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076677-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076677-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076677-003CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076677-004CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076677-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076677-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076677-003CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076677-004CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A076677-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076677-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076677-003CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076677-004CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076677-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076677-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076677-003CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076677-004CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076677-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076677-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076677-003CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076677-004CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076677-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076677-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076677-003CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076677-004CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076677-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076677-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076677-003CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076677-004CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-272680178bc6a6…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEMylan Pharmaceuticals Inc.487ae0f0-320c-4534-b9e2-0e215f167cea2022-01-12WarningsExact identifier
ndc (product): 0378-3637
4ff5ce14-77ce-4757-a40e-e7099f15a011abaf61ad-17bd-4dcf-aff1-6687c4cb1b9f2010-04-07WarningsExact identifier
spl id: 4ff5ce14-77ce-4757-a40e-e7099f15a011
spl set id: abaf61ad-17bd-4dcf-aff1-6687c4cb1b9f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.