RANITIDINE - ACID REDUCER- ranitidine hydrochloride tablet, film coated 
Chain Drug Consortium, LLC.

----------

Drug Facts

ACTIVE INGREDIENT (IN EACH TABLET)

Ranitidine 75 mg (as ranitidine hydrochloride USP, 84 mg)

PURPOSE

Acid reducer

USES

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

WARNINGS

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

Do not use

if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
with other acid reducers

Ask a doctor before use if you have

frequent chest pain
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain
had heartburn over 3 months. This may be a sign of a more serious condition.
heartburn with lightheadedness, sweating or dizziness
chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness

Stop use and ask a doctor if

your heartburn continues or worsens
you need to take this product for more than 14 days

If pregnant or breast-feeding,

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 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

TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP 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

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, talc, titanium dioxide

QUESTIONS?

call 1-800-406-7984

Read the directions, consumer information leaflet and warnings before use.

Keep the carton. It contains important information.

DISTRIBUTED BY

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101, BOCA RATON, FL 33431

PRINCIPAL DISPLAY PANEL

Premier Value®

NDC 68016-352-60

Ranitidine Tablets, USP 75 mg

Acid Reducer

Regular Strength

60 Tablets

Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

Compare to the active ingredient of Zantac 75®

This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals Inc., owner of the registered trademark Zantac 75®.

This is the 60 count bottle carton label for Premier Value Ranitidine tablets, USP 75 mg.
RANITIDINE - ACID REDUCER 
ranitidine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-352
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE75 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize8mm
FlavorImprint Code OR;606
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-352-6060 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:68016-352-3030 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20174507/10/2012
Labeler - Chain Drug Consortium, LLC. (101668460)
Registrant - Ohm Laboratories Inc. (184769029)
Establishment
NameAddressID/FEIBusiness Operations
Shasun Pharmaceuticals Limited915786829MANUFACTURE(68016-352)

Revised: 10/2015
Document Id: f48d12b3-6601-461a-97f0-6b233e5ac724
Set id: 92e1e60c-be24-4b20-8a2a-a39d03cc3cf3
Version: 2
Effective Time: 20151006
 
Chain Drug Consortium, LLC.