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NDC 68196-0102-01 SIMPLY RIGHT 5 mg/5mL Details

SIMPLY RIGHT 5 mg/5mL

SIMPLY RIGHT is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Sam's West 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: 68196-0102-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Cetirizine

Product Information

NDC	68196-0102
Product ID	68196-102_351aad60-18d7-4c75-bb72-5e05538da592
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	SIMPLY RIGHT
Proprietary Name Suffix	childrens cetirizine
Non-Proprietary Name	Cetirizine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	mg/5mL
Substance Name	CETIRIZINE HYDROCHLORIDE
Labeler Name	Sam's West Inc
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA090182
Listing Certified Through	2024-12-31

Package

Package Images

NDC 68196-0102-01 (68196010201)

Pricing Information	N/A
NDC Package Code	68196-102-01
Billing NDC	68196010201
Package	2 BOTTLE in 1 CARTON (68196-102-01) / 240 mL in 1 BOTTLE
Marketing Start Date	2011-09-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 48b47541-cf0c-48a7-9a65-2158fd1284f1 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

Cetirizine HCl 5 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

use only with enclosed dosing cup
find right dose on chart below
mL = milliliter

adults and children 6 years and over	5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.
adults 65 years and over	5 mL once daily; do not take more than 5 mL in 24 hours.
children 2 to under 6 years of age	2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

do not use if carton is opened or if imprinted safety seal is broken or missing
see bottom panel for lot number and expiration date
store between 20° to 25°C (68° to 77°F)

Inactive ingredients

artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucralose

Questions?

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:

SAM'S WEST, INC.

BENTONVILLE, AR 72716

PRINCIPAL DISPLAY PANEL - 2 x 240 mL Bottle Carton

Twin Pack – 2 X 8 FL OZ

Compare to Children's Zyrtec® active ingredient*

NDC 68196-102-07

Member's Mark™

24 hour relief

original prescription strength

children's

cetirizine

hydrochloride oral solution

1 mg/mL antihistamine

allergy

24 hour relief of:

• Sneezing; runny nose; itchy,

watery eyes; itchy throat or nose

• Indoor & outdoor allergies

• Sugar free • Dye free

2 years and older

Grape flavor

Dosing cup included

Contains 2 bottles of 8 FL OZ (240 mL)

each/total 16 FL OZ (480mL)

PRINCIPAL DISPLAY PANEL - 2 x 240 mL Bottle Carton

INGREDIENTS AND APPEARANCE

SIMPLY RIGHT CHILDRENS CETIRIZINE

cetirizine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68196-102
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24)	Cetirizine Hydrochloride	5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
acetic acid (UNII: Q40Q9N063P)
glycerin (UNII: PDC6A3C0OX)
methylparaben (UNII: A2I8C7HI9T)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
sodium acetate anhydrous (UNII: NVG71ZZ7P0)
sucralose (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	YELLOW (colorless to slightly yellow)	Score
Shape		Size
Flavor	GRAPE (sugar free)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68196-102-02	2 in 1 CARTON	09/08/2011
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:68196-102-01	2 in 1 CARTON	09/08/2011
2		240 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:68196-102-07	2 in 1 CARTON	09/08/2011
3		240 mL 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	ANDA090182	09/08/2011

Labeler - Sam's West Inc (051957769)

Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Name	Address	ID/FEI	Business Operations
Establishment
Taro Pharmaceutical Industries Ltd.		600072078	MANUFACTURE(68196-102)

Revised: 7/2021

Document Id: 351aad60-18d7-4c75-bb72-5e05538da592

Set id: 48b47541-cf0c-48a7-9a65-2158fd1284f1

Version: 4

Effective Time: 20210720

Search by Drug Name or NDC

NDC 68196-0102-01 SIMPLY RIGHT 5 mg/5mL Details

SIMPLY RIGHT 5 mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 68196-0102-01 (68196010201)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 48b47541-cf0c-48a7-9a65-2158fd1284f1 Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each 5 mL)

Purpose

Uses

Warnings

When using this product

If pregnant or breast-feeding

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 2 x 240 mL Bottle Carton

INGREDIENTS AND APPEARANCE

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