Drug Facts

Set ID
a6f55152-a88d-4894-9756-758dbde6e7d2
Manufacturer
Select Brand | Ranbaxy Pharmaceuticals Inc. | Ohm Laboratories Inc.
Effective date
2012-09-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:33:13

Key Label Information

Active Ingredients And Purpose

ACTIVE INGREDIENT (IN EACH CAPLET)

Cetirizine HCl, USP 10 mg

PURPOSE

Antihistamine

Uses

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

WARNINGS

Directions And Dosage

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 Label Information

INACTIVE INGREDIENTS

Corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

select brand ® NDC 15127-909-30 Original Prescription Strength Allergy Cetirizine HCl Tablets, 10 mg Antihistamine Indoor & Outdoor Allergies † Compare to the active ingredient of Zyrtec ® 24 Hour Relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 30 Tablets 10 mg EACH Distributed by: SELECT BRAND ® DISTRIBUTORS 5087905/0811

Products

NDC Codes

Ingredients

NameUNIIKind
CETIRIZINE HYDROCHLORIDE64O047KTOAACTIB
STARCH, CORNO8232NY3SJIACT
HYPROMELLOSES3NXW29V3WOIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOLS3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Complete SPL Sections

ACTIVE INGREDIENT (IN EACH CAPLET)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl, USP 10 mg

PURPOSE

OTC - PURPOSE SECTION

Antihistamine

USES

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. store between 20° to 25° C (68° to 77° F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide

QUESTIONS?

OTC - QUESTIONS SECTION

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

select brand ® NDC 15127-909-30 Original Prescription Strength Allergy Cetirizine HCl Tablets, 10 mg Antihistamine Indoor & Outdoor Allergies † Compare to the active ingredient of Zyrtec ® 24 Hour Relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 30 Tablets 10 mg EACH Distributed by: SELECT BRAND ® DISTRIBUTORS 5087905/0811

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

XML object
dailymed/a6f55152-a88d-4894-9756-758dbde6e7d2/f37b9fdc-9610-429f-bed4-d74893eda296.xml
XML SHA-256
fce5164bc9583a42fec9084bb8d27687acdd32991775ed65d977826261c4fccb
XML bytes
29924

Legacy File Index

FolderFileDate
otcCet.jpg2012-10-08
otcf37b9fdc-9610-429f-bed4-d74893eda296.xml2012-10-08