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NDC 70000-0148-01 Allergy Relief 10 mg/1 Details

Allergy Relief 10 mg/1

Allergy Relief is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health (Leader) 70000. 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: 70000-0148-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Cetirizine

Product Information

NDC	70000-0148
Product ID	70000-0148_4b22220b-b524-449f-a865-61f6ac4b39a2
Associated GPIs	41550020100320
GCN Sequence Number	017037
GCN Sequence Number Description	cetirizine HCl TABLET 10 MG ORAL
HIC3	Z2Q
HIC3 Description	ANTIHISTAMINES - 2ND GENERATION
GCN	49291
HICL Sequence Number	006544
HICL Sequence Number Description	CETIRIZINE HCL
Brand/Generic	Generic
Proprietary Name	Allergy Relief
Proprietary Name Suffix	All Day
Non-Proprietary Name	Cetirizine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	CETIRIZINE HYDROCHLORIDE
Labeler Name	Cardinal Health (Leader) 70000
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA078780
Listing Certified Through	n/a

Package

Package Images

NDC 70000-0148-01 (70000014801)

Pricing Information	N/A
NDC Package Code	70000-0148-1
Billing NDC	70000014801
Package	1 BLISTER PACK in 1 CARTON (70000-0148-1) / 14 TABLET in 1 BLISTER PACK
Marketing Start Date	2016-09-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b8d71e0a-6953-41e0-af25-5fd9a1a48a91 Details

Active ingredient (in each tablet)

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
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 right away.

Directions

adults and children 6 years and over	Take 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 (68-77°F)

Inactive ingredients

lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, povidone, starch, talc, titanium dioxide

Questions or comments?

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

Principal Display Panel

All Day

Allergy

Cetirizine HCI Tablets 10 mg | Antihistamine

24 hour relief of

Running Nose, Sneezing,

Itchy Throat or Nose,

and & Itchy, Watery Eyes

COMPARE TO ZYRTEC® active ingredient*

TABLETS

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Zyrtec®.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Product Label

LEADER All Day Allergy

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF ALL DAY

cetirizine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0148
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	IP46
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0148-1	1 in 1 CARTON	09/30/2016	12/31/2023
1		14 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:70000-0148-4	1 in 1 BOX	09/30/2016	12/31/2023
2		90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:70000-0148-2	1 in 1 BOX	09/30/2016	12/31/2023
3		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC:70000-0148-3	1 in 1 BOX	09/30/2016	12/31/2023
4		70 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078780	09/30/2016	12/31/2023

Labeler - Cardinal Health (Leader) 70000 (063997360)

Revised: 9/2021

Document Id: 4b22220b-b524-449f-a865-61f6ac4b39a2

Set id: b8d71e0a-6953-41e0-af25-5fd9a1a48a91

Version: 4

Effective Time: 20210930