ALLERGY RELIEF- cetirizine hydrochloride tablet, coated

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

Buy It Now

Active ingredient:
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)
Available from:
AAA PHARMACEUTICAL, 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:
57344-194-01

ALLERGY RELIEF- cetirizine hydrochloride tablet, coated

AAA PHARMACEUTICAL, INC.

----------

RES - 1194A - 2019-0911

Drug Facts

Active ingredient (in each tablet)

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 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

ask a doctor

over

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)

retain carton for complete product information and warnings

Inactive ingredients

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

stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

Questions or Comments?

1-844-705-4384

PRINCIPAL DISPLAY PANEL

RESTORE U

24 HR

NDC 57344-194-01

COMPARE TO THE ACTIVE INGREDIENT IN ZYRTEC®

Allergy Relief

Cetirizine Hydrochloride Tablets, 10 mg / Antihistamine

Indoor and Outdoor Allergies

Original Prescription Strength

Relieves: Sneezing, Runny Nose, Itchy, Watery Eyes, Itchy Nose or Throat

actual size

14 TABLETS

ALLERGY RELIEF

cetirizine hydrochloride tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:57344-19 4

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

AAA PHARMACEUTICAL, INC.

Ingredient Name

Stre ng th

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

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

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

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

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

Product Characteristics

Color

white (white to o ff white)

S core

2 pieces

S hap e

RECTANGLE (ro unded o ff rectangualr)

S iz e

9 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:57344-19 4-

1 in 1 CARTON

10 /0 1/20 18

1

14 in 1 BOTTLE, PLASTIC; 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

ANDA20 9 274

10 /0 1/20 18

Labeler -

AAA PHARMACEUT ICAL, INC. (181192162)

Revised: 9/2019

Similar products

Search alerts related to this product

View documents history

Share this information