Ranitidine by Dr. Reddy's Laboratories Limited RANITIDINE tablet

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 75 mg (as ranitidine hydrochloride, USP 84 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

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 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)
  • do not chew tablet
• children under 12 years: ask a doctor

Other information

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

Inactive ingredients

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

QUESTIONS

Questions? call 1-888-375-3784

Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information.

PRINCIPAL DISPLAY PANEL

Ranitidine Tablets USP, 75 mg - container label

PRINCIPAL DISPLAY PANEL

Ranitidine Tablets USP, 75 mg - Container CartonLabel

INGREDIENTS AND APPEARANCE

RANITIDINE 
ranitidine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55111-131
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ranitidine hydrochloride (UNII: BK76465IHM) (ranitidine - UNII:884KT10YB7)	ranitidine	75 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
magnesium stearate (UNII: 70097M6I30)
cellulose, microcrystalline (UNII: OP1R32D61U)
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)
ferrosoferric oxide (UNII: XM0M87F357)
titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	P75
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55111-131-30	1 in 1 CARTON	03/01/2000
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 55111-131-60	1 in 1 CARTON	03/01/2000
2		60 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 55111-131-80	1 in 1 CARTON	03/01/2000
3		80 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 55111-131-90	1 in 1 CARTON	03/01/2000
4		90 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 55111-131-04	1 in 1 CARTON	03/01/2000
5		120 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 55111-131-37	1 in 1 CARTON	03/01/2000
6		160 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 55111-131-79	1 in 1 CARTON	03/01/2000
7		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
8	NDC: 55111-131-14	2 in 1 CARTON	03/01/2000
8		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
9	NDC: 55111-131-81	3 in 1 CARTON	03/01/2000
9		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
10	NDC: 55111-131-45	1 in 1 CARTON	03/01/2000
10		45 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	ANDA075294	03/01/2000

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