Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

ACID REDUCER- ranitidine tablet 
Ohm Laboratories Inc.

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Drug Facts

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Acid reducer

INDICATIONS AND USAGE

• 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

• 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
• frequent chest pain
• frequent wheezing, particularly with heartburn
• unexplained weight loss
• nausea or vomiting
• stomach pain
• 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.

OTC - 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).

DOSAGE AND ADMINISTRATION

• 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

SPL UNCLASSIFIED

• 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 INGREDIENT

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

OTC - QUESTIONS

Call 1-800-406-7984

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†Compare To the active ingredient of Zantac 150®

NDC: 51660-351-60

Maximum Strength

ohm®

Ranitidine Tablets, USP 150 mg

Acid Reducer

• Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

60 TABLETS

ACID REDUCER 
ranitidine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51660-351
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 GLYCOL, UNSPECIFIED (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: 51660-351-24	24 in 1 CARTON	03/30/2012	09/11/2019
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 51660-351-50	1 in 1 CARTON	03/30/2012	09/11/2019
2		50 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 51660-351-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2012	09/11/2019
4	NDC: 51660-351-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	10/16/2014	09/11/2019
5	NDC: 51660-351-66	65 in 1 BOTTLE; Type 0: Not a Combination Product	04/23/2012	09/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA200536	06/28/2011	09/11/2019

Labeler - Ohm Laboratories Inc. (184769029)

Establishment
Name	Address	ID/FEI	Business Operations
Strides Shasun Limited		915786829	MANUFACTURE(51660-351)

Revised: 9/2019

Document Id: 1d48ad0a-c4af-4bf9-b4b4-40a63f6abfba

34390-5

Set id: 5ed9341a-38a9-4d0c-bf48-882a1b4a35c5

Version: 6

Effective Time: 20190911