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CETIRIZINE HYDROCHLORIDE by Apotheca Inc.

Medically reviewed on Apr 9, 2018

Dosage form: tablet
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: Apotheca Inc.
NDC Code: 12634-987

Cetirizine 10mg Tablets, Allergy Tablets DRUG FACTS

ACTIVE INGREDIENT(in each Tablet)
Cetirizine HCI 10mg

PURPOSEANTIHISTAMINE
24 Hour Relief of Indoor and Outdoor Allergies

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
  • 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 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 Poison Control Center right away.

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.
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 ingredientsOther 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 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 PANELNDC 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

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12634-987(NDC:0378-3637)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
MAGNESIUM STEARATE 
HYPROMELLOSE 
TITANIUM DIOXIDE 
Product Characteristics
Colorwhite (WHITE) Scoreno score
ShapeBULLET (Barrel Shaped) Size8mm
FlavorImprint CodeM;C37
Contains    
Packaging
#Item CodePackage Description
1NDC:12634-987-966 TABLET (TABLET) in 1 BOTTLE, PLASTIC
2NDC:12634-987-977 TABLET (TABLET) in 1 BOTTLE, PLASTIC
3NDC:12634-987-0010 TABLET (TABLET) in 1 BOTTLE, PLASTIC
4NDC:12634-987-8020 TABLET (TABLET) in 1 BOTTLE, PLASTIC
5NDC:12634-987-7130 TABLET (TABLET) in 1 BOTTLE, PLASTIC
6NDC:12634-987-5050 TABLET (TABLET) in 1 BOTTLE, PLASTIC
7NDC:12634-987-01100 TABLET (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07667701/01/2010
Labeler - Apotheca Inc. (051457844)
Establishment
NameAddressID/FEIOperations
Apotheca Inc.051457844repack, relabel

 
Apotheca Inc.

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Further information

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