ALLERGY RELIEF- cetirizine hcl capsule

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

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Active ingredient:
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)
Available from:
MEIJER, 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:
41250-741-25

ALLERGY RELIEF- cetirizine hcl capsule

MEIJER, INC.

----------

Cetirizine Hydrochloride Tablets

Active Ingredient (in each capsule)

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 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

or kidney disease

ask a doctor

Other Information

store at 20º to 25 C (68 to 77 F)

avoid high humidity and excessive heat above 40

C (104 F)

protect from light

Inactive Ingredients

Butylated hydroxytolene, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400,

purified water, sodium hydroxide, Sorbitan, Sorbitol

Questions or comments?

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

Principal Display Panel

*Compare to the active ingredient in Zyrtec®

24 hour allergy relief

Cetirizine HCl Capsules | 10 mg

Antihistamine

ORIGINAL PRESCRIPTION STRENGTH,

INDOOR & OUTDOOR ALLERGIES

24 Hour Relief of:

Sneezing, Runny nose, Itchy, watery eyes, Itchy throat or nose

Softgels**

(**Liquid-Filled Capsules)

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

of Zyrtec®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN

OR MISSING.

KEEP OUTER CARD FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPID, MI 49544

www.meijer.com

Product Label

MEIJER 24 Hour Allerg y

ALLERGY RELIEF

cetirizine hcl capsule

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41250 -741

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

MEIJER, INC.

Ingredient Name

Stre ng th

GELATIN (UNII: 2G8 6 QN327L)

GLYCERIN (UNII: PDC6 A3C0 OX)

MANNITO L (UNII: 3OWL53L36 A)

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

SO RBITAN (UNII: 6 O9 2ICV9 RU)

SO RBITO L (UNII: 50 6 T6 0 A25R)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

Product Characteristics

Color

YELLOW (clear)

S core

no sco re

S hap e

OVAL

S iz e

13mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:41250 -741-25

1 in 1 BOX

0 3/31/20 18

1

25 in 1 BOTTLE; 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 7235

0 3/31/20 18

Labeler -

MEIJER, INC. (006959555)

Revised: 7/2020

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