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NDC 70518-2886-00 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 REMEDYREPACK 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: 70518-2886-00
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Cetirizine

Product Information

NDC	70518-2886
Product ID	70518-2886_d784b172-4aba-d05a-e053-2a95a90a2f43
Associated GPIs	41550020100320
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	Allergy Relief
Proprietary Name Suffix	n/a
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	REMEDYREPACK INC.
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA209274
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70518-2886-00 (70518288600)

Pricing Information	N/A
NDC Package Code	70518-2886-0
Billing NDC	70518288600
Package	28 TABLET in 1 BLISTER PACK (70518-2886-0)
Marketing Start Date	2020-09-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 52a07715-d488-492a-8317-ce0a8d438803 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 (1-800-222-1222) 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 20º to 25ºC (68º to 77ºF)
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 1-888-588-1418 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the active ingredient in Zyrtec®

Allergy Relief

Cetirizine HCl Tablets USP, 10 mg/Antihistamine

Indoor & Outdoor Allergies

24 hour relief of

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Original Prescription Strength

Tablets

*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 CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PRINCIPAL DISPLAY PANEL

DRUG: Allergy Relief

GENERIC: Cetirizine HCl

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-2886-0

COLOR: white

SHAPE: OVAL

SCORE: Two even pieces

SIZE: 9 mm

IMPRINT: G;4

PACKAGING: 28 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

CETIRIZINE HYDROCHLORIDE 10mg in 1

INACTIVE INGREDIENT(S):

LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
MICROCRYSTALLINE CELLULOSE

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF

cetirizine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70518-2886(NDC:69230-304)
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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	9mm
Flavor		Imprint Code	G;4
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70518-2886-0	28 in 1 BLISTER PACK; Type 0: Not a Combination Product	09/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA209274	09/15/2020

Labeler - REMEDYREPACK INC. (829572556)

Revised: 2/2022

Document Id: d784b172-4aba-d05a-e053-2a95a90a2f43

Set id: 52a07715-d488-492a-8317-ce0a8d438803

Version: 3

Effective Time: 20220208