Drug Facts

Set ID
0f140a8c-8736-40bb-8869-61d9b5b985da
Manufacturer
Select Brand | Shasun Pharmaceuticals Limited
Effective date
2012-10-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:39:05

Key Label Information

Active Ingredients And Purpose

ACTIVE INGREDIENT (IN EACH TABLET)

Ranitidine 150 mg (as ranitidine hydrochloride USP, 168 mg)

PURPOSE

Acid reducer

Uses

USES

relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by certain foods and beverages

Warnings

WARNINGS

Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

Directions And Dosage

DIRECTIONS

adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn can be used up to twice daily (do not take more than 2 tablets in 24 hours) children under 12 years: ask a doctor

Other Label Information

INACTIVE INGREDIENTS

Colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

select brand ® NDC 15127-340-24 Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Prevents & Relieves Heartburn Associated wit Acid Indigestion & Sour Stomach † Compare to the active ingredient of Zantac 150 ® 24 Tablets Distributed by: SELECT BRAND ® DISTRIBUTORS 5093019/0112

Products

NDC Codes

Ingredients

NameUNIIKind
RANITIDINE HYDROCHLORIDEBK76465IHMACTIM
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYPROMELLOSES3NXW29V3WOIACT
FERRIC OXIDE RED1K09F3G675IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOLS3WJQ0SDW1AIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Complete SPL Sections

ACTIVE INGREDIENT (IN EACH TABLET)

OTC - ACTIVE INGREDIENT SECTION

Ranitidine 150 mg (as ranitidine hydrochloride USP, 168 mg)

PURPOSE

OTC - PURPOSE SECTION

Acid reducer

USES

INDICATIONS & USAGE SECTION

relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by certain foods and beverages

WARNINGS

WARNINGS SECTION

Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn can be used up to twice daily (do not take more than 2 tablets in 24 hours) children under 12 years: ask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN. store at 20° - 25° C (68° - 77° F) avoid excessive heat or humidity this product is sodium and sugar free

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide

QUESTIONS?

OTC - QUESTIONS SECTION

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

select brand ® NDC 15127-340-24 Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Prevents & Relieves Heartburn Associated wit Acid Indigestion & Sour Stomach † Compare to the active ingredient of Zantac 150 ® 24 Tablets Distributed by: SELECT BRAND ® DISTRIBUTORS 5093019/0112

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc9d228d53-a9ff-4391-8395-77580924fc26.xml2014-04-24
otcsbrani150.jpg2014-04-24