ALLERGY RELIEF- cetirizine hcl 10 mg tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)
Available from:
Genomma Labs USA, Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine 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
Authorization status:
Abbreviated New Drug Application
Authorization number:
50066-396-09, 50066-396-45

ALLERGY RELIEF- cetirizine hcl 10 mg tablet

Genomma Labs USA, Inc

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Drug Facts

Active ingredient

Cetirizine HCl 10 mg

Purpos e

Antihistamine

Us es

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 doctor if you have

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

Ask doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

drowsiness may occur

avoid alcoholic drinks

alcohol, sedatives, and tranquilizers may increase drowsiness

be careful when drivinga motor vehicle or operating machinery

Stop use and ask doctor

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

If pregnant or breast feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep Out of Reach of Children

In case of accidental overdose, contact a octor or Poison Control Center (1-800-222-1222) right away.

Directions

Adults and children 6 years and over: one 10mg tablet once daily; do not take more than one 10mg

tablet in 24 hours. A 5mg 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°C to 25°C (68°F to 77°F)

do not use if blister unit is broken or torn

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium

stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Package/Label Principal Display Panel

Next Allerg y

ALLERGY RELIEF

cetirizine hcl 10 mg tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 0 6 6 -39 6

Genomma Labs USA, Inc

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CETIRIZINE HYDRO CHLO RIDE (UNII: 6 4O0 47KTOA) (CETIRIZINE -

UNII:YO726 1ME24)

CETIRIZINE

HYDROCHLORIDE

10 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

Product Characteristics

Color

WHITE

S core

2 pieces

S hap e

RECTANGLE (pillo w-shaped)

S iz e

9 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End Date

1

NDC:50 0 6 6 -39 6 -

1 in 1 CARTON

12/16 /20 14

1

10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n

Pro duc t

2

NDC:50 0 6 6 -39 6 -45

3 in 1 CARTON

12/16 /20 14

2

15 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 78 317

12/16 /20 14

Labeler -

Genomma Labs USA, Inc (832323534)

Revised: 9/2019

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