REGULAR STRENGTH ACID REDUCER- ranitidine tablet

Regular Strength Acid Reducer by

Drug Labeling and Warnings

Regular Strength Acid Reducer by is a Otc medication manufactured, distributed, or labeled by Family Dollar, 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 any 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 minutesbefore 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 INDIVIDUAL BLISTER IS OPEN OR TORN
• store at 20º - 25ºC (68º - 77ºF)
• avoid excessive heat or humidity
• this product is sodium and sugar free

Inactive ingredients

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

Questions

call 1-800-406-7984

Principal display panel

FAMILY
wellness

COMPARE TO THE ACTIVE INGREDIENT OF ZANTAC 150*

Maximum Strength
Acid Reducer
Ranitidine Tablets, USP 150 mg

Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

24 TABLETS

DISTRIBUTED BY
FAMILY DOLLAR SERVICES, INC.,
10401 MONROE RD,
MATTHEWS, NC 28105 USA

5110360 0614

MADE IN INDIA

 

Ranitidine_150mg_24's

INGREDIENTS AND APPEARANCE

REGULAR STRENGTH ACID REDUCER 
ranitidine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-351
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: 55319-351-24	3 in 1 CARTON
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 55319-351-65	1 in 1 CARTON
2		65 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	06/28/2011

Labeler - Family Dollar (024472631)

Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)

Establishment
Name	Address	ID/FEI	Business Operations
Shasun Pharmaceuticals Limited		915786829	API MANUFACTURE(55319-351)