ACID REDUCER- ranitidine tablet

Acid Reducer by

Drug Labeling and Warnings

Acid Reducer by is a Otc medication manufactured, distributed, or labeled by WinCo Foods, LLC, Ranbaxy Pharmaceuticals Inc., Shasun Pharmaceuticals Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT (IN EACH TABLET)

Ranitidine 150 mg (as ranitidine hydrochloride, USP 168 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 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
• if you have kidney disease, except under the advice and supervision of a doctor

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 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

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

QUESTIONS?

or to report an adverse event call 800-824-1706 Monday - Friday 9am - 4pm MST

DISTRIBUTED BY:

WINCO FOODS, LLC, BOISE, ID 83704

MADE IN INDIA

5113377/0914

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Zantac 150®

WinCo FOODS

MAXIMUM STRENGTH

RANITIDINE TABLETS, USP 150 mg/ACID REDUCER

Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

24 Tablets

INGREDIENTS AND APPEARANCE

ACID REDUCER 
ranitidine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-243
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)	RANITIDINE	150 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	9R
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67091-243-24	24 in 1 CARTON	01/08/2015
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA200536	08/15/2012

Labeler - WinCo Foods, LLC (056098817)

Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)

Establishment
Name	Address	ID/FEI	Business Operations
Shasun Pharmaceuticals Limited		915786829	MANUFACTURE(67091-243)