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NDC 70677-0075-02 Sunmark All Day Allergy 10 mg/1 Details

Sunmark All Day Allergy 10 mg/1

Sunmark All Day Allergy is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. 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: 70677-0075-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Cetirizine

Product Information

NDC	70677-0075
Product ID	70677-0075_33bab6b9-056c-4029-96a2-ab334cd04322
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	Sunmark All Day Allergy
Proprietary Name Suffix	n/a
Non-Proprietary Name	Cetirizine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	CETIRIZINE HYDROCHLORIDE
Labeler Name	Strategic Sourcing Services LLC
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA078336
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70677-0075-02 (70677007502)

Pricing Information
NDC Package Code	70677-0075-2
Billing NDC	70677007502
Package	1 BOTTLE in 1 CARTON (70677-0075-2) / 60 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date	2019-08-16
NDC Exclude Flag	N
Price Per Unit	0.06728
Pricing Unit	EA
Effective Date	2022-11-23
NDC Description	SM ALL DAY ALLERGY 10 MG TAB
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2022-11-23

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 938c97ad-a8f6-47ed-9819-382d5169a444 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
•: 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 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)
•: do not use if printed foil under cap is broken or missing

Inactive ingredients

corn starch, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO ZYRTEC® ACTIVE INGREDIENT

Original Prescription Strength

all day allergy

24 hour relief of

sneezing; runny nose;

itchy, watery eyes;

itchy throat or nose

Cetirizine Hydrochloride Tablets, 10mg

Antihistamine

Indoor & outdoor allergies

ALLERGY

Actual Size

30 TABLETS

INGREDIENTS AND APPEARANCE

SUNMARK ALL DAY ALLERGY

cetirizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70677-0075
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
STARCH, CORN (UNII: O8232NY3SJ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	4H2
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70677-0075-1	1 in 1 CARTON	08/21/2019
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:70677-0075-2	1 in 1 CARTON	08/16/2019
2		60 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:70677-0075-3	1 in 1 CARTON	08/21/2019
3		90 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	ANDA078336	08/16/2019

Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 11/2020

Document Id: 33bab6b9-056c-4029-96a2-ab334cd04322

Set id: 938c97ad-a8f6-47ed-9819-382d5169a444

Version: 2

Effective Time: 20201118