RANITIDINE tablet, coated

Ranitidine by

Drug Labeling and Warnings

Ranitidine by is a Otc medication manufactured, distributed, or labeled by Dr. Reddy's Laboratories 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

Use(s)

• 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

• 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
• kidney disease

Ask a doctor or pharmacist before use if you are

taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop use and ask 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

• do not use if printed foil under bottle cap is open or torn
• store at 20°-25°C (68°-77°F)
• avoid excessive heat or humidity
• protect from light
• this product is sodium and sugar free

Inactive ingredients

FD&C red #40 aluminum lake, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

Questions?

Call 1-888-375-3784

Read the directions and warnings before use. Keep the carton. It contains important information including tips for managing heartburn.

SPL UNCLASSIFIED SECTION

Tips for managing heartburn

• Do not lie flat or bend over soon after eating

• Do not eat late at night, or just before bedtime

• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, and even some fruits and vegetables.

• Eat slowly and do not eat beig meals

• If you are overweight, lose weight

• If you smoke, quit smoking

• Raise the head of your bed

• Wear loose fitting clothing around your stomach.

Revised: 03/20

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

Container Label:

Dr.Reddy's
NDC: 55111-404-34

Maximum Strength
Ranitidine
Tablets USP,150 mg
ACID REDUCER

PREVENTS & RELIEVES
HEARTBURN associated with acid indigestion
and sour stomach

24 Tablets(24 doses)

PRINCIPAL DISPLAY PANEL

Container Carton Label:

Dr.Reddy's
NDC: 55111-404-34

Compare to the active
ingredient in Zantact 150® Tablets*

Maximum Strength
Ranitidine
Tablets USP,150 mg
ACID REDUCER

PREVENTS & RELIEVES
heartburn associated with acid indigestion
and sour stomach

24 Tablets(24 doses)

PRINCIPAL DISPLAY PANEL

Blister Carton Label:

Dr.Reddy's
NDC: 55111-404-24

Maximum Strength
Ranitidine
Tablets USP,150 mg
ACID REDUCER

PREVENTS & RELIEVES
HEARTBURN associated with acid indigestion
and sour stomach

24 Tablets(24 doses)

INGREDIENTS AND APPEARANCE

RANITIDINE 
ranitidine tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55111-404
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
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
magnesium stearate (UNII: 70097M6I30)
cellulose, microcrystalline (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	R150
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55111-404-34	1 in 1 CARTON	12/02/2009
1		24 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 55111-404-32	1 in 1 CARTON	12/02/2009
2		32 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 55111-404-36	1 in 1 CARTON	12/02/2009
3		36 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 55111-404-50	1 in 1 CARTON	12/02/2009
4		50 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 55111-404-61	1 in 1 CARTON	12/02/2009
5		65 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 55111-404-55	2 in 1 CARTON	01/05/2010
6		65 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 55111-404-62	1 in 1 CARTON	12/02/2009
7		95 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 55111-404-90	2 in 1 CARTON	12/02/2009
8		95 in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 55111-404-02	1 in 1 CARTON	12/02/2009
9		200 in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 55111-404-65	1 in 1 CARTON	12/02/2009
10		220 in 1 BOTTLE; Type 0: Not a Combination Product
11	NDC: 55111-404-17	1 in 1 CARTON	12/02/2009
11		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
12	NDC: 55111-404-24	3 in 1 CARTON	12/02/2009
12		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
13	NDC: 55111-404-38	4 in 1 CARTON	12/02/2009
13		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
14	NDC: 55111-404-40	1 in 1 BOTTLE	12/02/2009
14		40 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	ANDA078192	12/02/2009

Labeler - Dr. Reddy's Laboratories Limited (650562841)