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NDC 63868-0432-25 All Day Allergy Relief 10 mg/1 Details

All Day Allergy Relief 10 mg/1

All Day Allergy Relief is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by QUALITY CHOICE (Chain Drug Marketing Association). 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: 63868-0432-25
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Cetirizine

Product Information

NDC	63868-0432
Product ID	63868-432_cee35bd7-dd9c-42b0-81ab-00fbc479f884
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	All Day Allergy Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Cetirizine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	CETIRIZINE HYDROCHLORIDE
Labeler Name	QUALITY CHOICE (Chain Drug Marketing Association)
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	n/a

Package

Package Images

NDC 63868-0432-25 (63868043225)

Pricing Information	N/A
NDC Package Code	63868-432-25
Billing NDC	63868043225
Package	1 BOTTLE in 1 BOX (63868-432-25) / 25 CAPSULE in 1 BOTTLE
Marketing Start Date	2018-06-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 02f5ba4b-dcd4-420d-9188-94139327667c 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

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 25oC (68o to 77o F)
avoid high humidity and excessive heat above 40oC (104oF)
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 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the Active Ingredient in ZYRTEC®

All Day Allergy Relief

Indoor & Outdoor Allergies

Cetirizine HCI Capsules, 10 mg

Antihistamine

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.

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Product Label

QUALITY CHOICE All Day Allergy Relief

INGREDIENTS AND APPEARANCE

ALL DAY ALLERGY RELIEF

cetirizine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-432
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
GELATIN (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)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63868-432-25	1 in 1 BOX	06/30/2018	02/23/2024
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	06/30/2018	02/23/2024

Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Revised: 11/2021

Document Id: cee35bd7-dd9c-42b0-81ab-00fbc479f884

Set id: 02f5ba4b-dcd4-420d-9188-94139327667c

Version: 3

Effective Time: 20211102