CETIRIZINE HYDROCHLORIDE (HIVES RELIEF)- cetirizine hydrochloride capsule

Cetirizine Hydrochloride (Hives Relief) by

Drug Labeling and Warnings

Cetirizine Hydrochloride (Hives Relief) by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC, APL HEALTHCARE LIMITED, Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Cetirizine HCl Capsules 10 mg (Hives Relief)

Drug Facts

Active ingredient (in each capsule)

Cetirizine HCI USP 10 mg

Purpose

Antihistamine

Uses

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

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 occuring. 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 DOCTOR/PHARMACIST

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.
• 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

• adults and children6 years and over: one 10 mg capsule once daily;; do not take more than one 10 mg; capsule 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 orkidney disease: ask a doctor

Other information

•  store between 20° - 25°C (68° - 77°F)
•  avoid high humidity and excessive heat above 40°C (104°F)
•  protect from light
•  do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing.

Inactive ingredients

black iron oxide, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution

Questions or comments?

call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)

Manufactured for:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Manufactured by:
Aurobindo Pharma Limited
Unit-VII (SEZ)
Mahabubnagar (Dt)-509302
India

M.L.No.: 22/MN/AP/2009/F/R

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (12's Capsule Container Label)

HIVES Relief     NDC: 58602-808-04
Original Prescription Strength

Cetirizine HCl Capsules
10 mg                                             CZ10
Antihistamine                            (Actual Size) 

READ AND KEEP THE OUTER PACKAGE FOR
COMPLETE WARNINGS AND INFORMATION

12 LIQUID GELS*
* LIQUID-FILLED CAPSULES
AUROHEALTH

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (12's Capsule Container Carton Label)

NDC: 58602-808-04
Original Prescription Strength
HIVES Relief

Cetirizine HCl Capsules
10 mg
Antihistamine

24 hour                                                      CZ10
Relief of itching due to hives               (Actual Size)

12 LIQUID GELS*
* LIQUID-FILLED CAPSULES
AUROHEALTH

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE (HIVES RELIEF) 
cetirizine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-808
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
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	YELLOW (Clear colourless to pale yellow viscous liquid)	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	CZ10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-808-04	1 in 1 CARTON	07/20/2018
1		12 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58602-808-53	1 in 1 CARTON	07/20/2018
2		25 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 58602-808-12	1 in 1 CARTON	07/20/2018
3		40 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 58602-808-16	65 in 1 CARTON	07/20/2018
4		65 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209107	07/20/2018

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
APL HEALTHCARE LIMITED		650844777	ANALYSIS(58602-808) , MANUFACTURE(58602-808)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		650381903	ANALYSIS(58602-808) , MANUFACTURE(58602-808)