Allergy relief tablet, film coated

Active ingredient (in each tablet)

Cetirizine HCl 10 mg

Purpose

Antihistamine

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.

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)

Directions

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 20-25 C (68-77 F)
  • do not use if printed foil under cap is broken or missing

Inactive ingredients

corn starch, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin

Questions or comments?

1-800-719-9260

Ingredients and appearance - Product information

Allergy relief tablet, film coated- Cetirizine hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 37808-583
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Cetirizine hydrochloride ( UNII: 64O047KTOA)( Cetirizine - UNII: YO7261ME24 ) 10 mgin 1

Inactive Ingredients

Ingredient Name Code
Starch, corn ( UNII: O8232NY3SJ)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Polydextrose ( UNII: VH2XOU12IE)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Povidone, unspecified ( UNII: FZ989GH94E)
Titanium dioxide ( UNII: 15FIX9V2JP)
Triacetin ( UNII: XHX3C3X673)

Product Characteristics

Color WHITE Size 10 mm
Shape OVAL Score 1
Imprint Code 4H2

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA078336 USA

Labeler - H E B( 007924756)

Principal display panel

Compare to Zyrtec ®active ingredient

Allergy Relief

Cetirizine Hydrochloride Tablets, 10 mg

Antihistamine

Indoor & Outdoor Allergies

Original Prescription Strength

24 Hour Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

24 Hour

actual size

30 TABLETS