CETIRIZINE HYDROCHLORIDE tablet, chewable

Cetirizine Hydrochloride by

Drug Labeling and Warnings

Cetirizine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Sun Pharmaceutical Industries, Inc., Sun Pharmaceutical Industries Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each chewable tablet)

For 5 mg:
Cetirizine hydrochloride 5 mg
 
For 10 mg:
Cetirizine hydrochloride 10 mg

Purpose

Antihistamine

Uses

relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Warnings

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

• trouble swallowing
• dizziness or loss of consciousness
• swelling of tongue
• swelling in or around mouth
• trouble speaking
• drooling
• wheezing or problems breathing

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.
 
Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use

• to prevent hives from any known cause such as:
  • foods
  • insect stings
  • medicines
  • latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.
• 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.
• hives that are an unusual color, look bruised or blistered
• hives that do not itch

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 doctor if

• an allergic reaction to this product occurs. Seek medical help right away.
• symptoms do not improve after 3 days of treatment
• the hives have lasted more than 6 weeks

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

• may be taken with or without water

For 5 mg:

• adults and children 6 years and over: 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
• adults 65 years and over: 1 tablet once a day; do not take more than 1 tablet 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 inner safety seal is open or torn
• see top layer for lot number and expiration date

Inactive ingredients

acesulfame potassium, colloidal silicon dioxide, compressible sugar, crospovidone, FD & C Blue No # 2 Aluminum Lake, FD & C Red No # 40 Aluminum Lake, guar gum, magnesium oxide light powder, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, prosweet N & A flavor powder, talc, tutti frutti flavor

Questions?

Call toll free 1-800-818-4555 weekdays

Principal Display Panel

For 5 mg Hives Relief:
Original Prescription Strength
NDC: 47335-343-16
Children's
Cetirizine Hydrochloride Chewable Tablets
5 mg
HIVES Relief
Antihistamine
24 hour Relief of ITCHING Due to Hives
Tutti-frutti Flavor
6 yrs. & older
100 CHEWABLE TABLETS
SUN PHARMACEUTICAL INDUSTRIES LTD.

For 10 mg Hives Relief:
Original Prescription Strength
NDC: 47335-344-16
Children's
Cetirizine Hydrochloride Chewable Tablets
10 mg
HIVES Relief
Antihistamine
Tutti-frutti Flavor
6 yrs. & older
100 CHEWABLE TABLETS
SUN PHARMACEUTICAL INDUSTRIES LTD.

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47335-343
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUCROSE (UNII: C151H8M554)
CROSPOVIDONE (UNII: 68401960MK)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GUAR GUM (UNII: E89I1637KE)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	PURPLE	Score	no score
Shape	ROUND	Size	8mm
Flavor	TUTTI FRUTTI	Imprint Code	343
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47335-343-15	30 in 1 BOTTLE; Type 0: Not a Combination Product	09/26/2011
2	NDC: 47335-343-16	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/26/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090142	09/26/2011

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47335-344
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUCROSE (UNII: C151H8M554)
CROSPOVIDONE (UNII: 68401960MK)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GUAR GUM (UNII: E89I1637KE)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	PURPLE	Score	no score
Shape	ROUND	Size	10mm
Flavor	TUTTI FRUTTI	Imprint Code	344
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47335-344-15	30 in 1 BOTTLE; Type 0: Not a Combination Product	09/26/2011
2	NDC: 47335-344-16	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/26/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090142	09/26/2011

Labeler - Sun Pharmaceutical Industries, Inc. (146974886)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Pharmaceutical Industries Limited		725959238	ANALYSIS(47335-343, 47335-344) , MANUFACTURE(47335-343, 47335-344)