Search by Drug Name or NDC

NDC 41250-0618-63 24 hour allergy 10 mg/1 Details

24 hour allergy 10 mg/1

24 hour allergy is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Meijer Distribution Inc. The primary component is CETIRIZINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Cetirizine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and allergy to other substances (such as dust mites, animal dander, cockroaches, and molds). These symptoms include sneezing; runny nose; itchy, red, watery eyes; and itchy nose or throat. Cetirizine is also used to treat itching and redness caused by hives. However, cetirizine does not prevent hives or other allergic skin reactions. Cetirizine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Cetirizine is also available in combination with pseudoephedrine (Sudafed, others). This monograph only includes information about the use of cetirizine alone. If you are taking the cetirizine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.

Related Packages: 41250-0618-63
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cetirizine

Product Information

NDC	41250-0618
Product ID	41250-618_6511653d-8712-4cd5-86bf-307042127dc7
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	24 hour allergy
Proprietary Name Suffix	n/a
Non-Proprietary Name	Cetirizine hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	CETIRIZINE HYDROCHLORIDE
Labeler Name	Meijer Distribution Inc
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA207235
Listing Certified Through	2024-12-31

Package

Package Images

NDC 41250-0618-63 (41250061863)

Pricing Information	N/A
NDC Package Code	41250-618-63
Billing NDC	41250061863
Package	1 BOTTLE in 1 PACKAGE (41250-618-63) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Start Date	2020-06-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e64db82c-6632-421e-8212-e0879445c4d6 Details

Active ingredient (in each capsule)

Cetirizine HCl 10 mg

Purpose

Antihistamine

Uses

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 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

•: avoid high humidity and excessive heat above 40°C (104°F)
•: protect from light

Inactive ingredients

butylated hydroxytoluene, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, sorbitan, sorbitol

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Zyrtec® Liquid Gels active ingredient

24 hour allergy

Cetirizine Hydrochloride Capsules 10 mg Antihistamine

INDOOR & OUTDOOR ALLERGIES

24 HOUR RELIEF OF:

Sneezing; Runny Nose; Itchy Watery Eyes; Itchy Throat or Nose

25 Liquid Gels**

**Liquid Filled Capsules

actual size

ORIGINAL PRESCRIPTION STRENGTH

INGREDIENTS AND APPEARANCE

24 HOUR ALLERGY

cetirizine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-618
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
MANNITOL (UNII: 3OWL53L36A)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	YELLOW	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	10
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41250-618-63	1 in 1 PACKAGE	06/02/2020
1		25 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA207235	06/02/2020

Labeler - Meijer Distribution Inc (006959555)

Revised: 6/2020

Document Id: 6511653d-8712-4cd5-86bf-307042127dc7

Set id: e64db82c-6632-421e-8212-e0879445c4d6

Version: 2

Effective Time: 20200604