ACID REDUCER- ranitidine tablet

Acid Reducer by

Drug Labeling and Warnings

Acid Reducer by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, 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 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
• 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 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, talc, titanium dioxide

QUESTIONS?

call 1-800-406-7984

PRINCIPAL DISPLAY PANEL - 150 mg Tablet Blister Pack Carton

MAJOR®
NDC: 0904-6350-24

MAXIMUM STRENGTH

RANITIDINE 150
Ranitidine Tablets USP, 150 mg
Acid Reducer

Prevents and Relieves
Hearburn Associated with Acid Indigestion and Sour Stomach

COMPARE TO the active ingredient of
ZANTAC 150®*

ACTUAL SIZE

24 Tablets

INGREDIENTS AND APPEARANCE

ACID REDUCER 
ranitidine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6350
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)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6350-24	1 in 1 CARTON	10/01/2013
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0904-6350-51	1 in 1 CARTON	10/01/2013	10/31/2019
2		50 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA200536	10/01/2013

Labeler - Major Pharmaceuticals (191427277)

Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)

Establishment
Name	Address	ID/FEI	Business Operations
Shasun Pharmaceuticals Limited		915786829	manufacture(0904-6350)