ALLERGY RELIEF- cetirizine hcl tablet

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

Buy It Now

Active ingredient:
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)
Available from:
Freds 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 if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. liver or kidney disease. Your doctor should determine if you need a different dose.  taking tranquilizers or sedatives. an allergic reaction to this product occurs. Seek medical help right away.
Authorization status:
Abbreviated New Drug Application
Authorization number:
55315-806-05

ALLERGY RELIEF- cetirizine hcl tablet

Freds Inc

----------

Cetirizine Hydrochloride Tablets

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

Warning

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

alcohol, sedatives, and tranquilizers may increase drowsiness

avoid alcoholic drinks

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 (1-800-222-1222) 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. 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 - 25 C (68 to 77 F)

contains no ingredient made from a gluten-containing grain (wheat, barley or rye)

Inactive ingredients

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

stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the active ingredient in Zyrtec®

ALLERGY RELIEF

Cetirizine HCI

Antihistamine

10 mg tablets

INDOOR & OUTDOOR ALLERGIES

24 HOUR RELIEF OF:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

TABLETS

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor

of Zyrtec®

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS

TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: fred's Inc.

4300 NEW GETWELL ROAD,

MEMPHIS, TN 38118

www.freds inc.com

Product Label

FRED'S PHARMACY Allerg y Relief

ALLERGY RELIEF

cetirizine hcl tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:55315-8 0 6

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

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

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

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

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)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

OVAL

S iz e

9 mm

Freds Inc

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:55315-8 0 6 -0 5

5 in 1 CARTON

0 2/28 /20 19

1

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

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 9 274

0 2/28 /20 19

Labeler -

Freds Inc (005866116)

Revised: 3/2019

Similar products

Search alerts related to this product

View documents history

Share this information