ZANTAC- ranitidine tablet, coated

Zantac by

Drug Labeling and Warnings

Zantac by is a Otc medication manufactured, distributed, or labeled by Central Texas Community Health Centers, Travis County Healthcare District. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

• Active ingredient (in each tablet): Purpose
• Ranitidine 75 mg (as ranitidine hydrochloride 84 mg) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .: 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

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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

• do not use if printed foil under bottle cap is open or torn (bottles)
• do not use if individual blister unit is open or torn (blisters)
• do not use if individual foil packet is open or torn (pouch)
• store at 20-25ºC (68-77ºF)
• avoid excessive heat or humidity
• this product is sodium and sugar free

Inactive ingredients

hypromellose, magnesium stearate, microcrystalline cellulose, iron oxide, titanium dioxide, triacetin

Questions?

call 1-888-285-9159 (English/Spanish) M – F, 8:30 – 5 EST, or visit www.zantacotc.com

SPL UNCLASSIFIED SECTION

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

Distributed by: Boehringer Ingelheim (BI) Consumer Health Care Products
Division of BI Pharmaceuticals, Inc., Ridgefield, CT 06877
© 2016, BI Pharmaceuticals, Inc. All rights reserved.
Product of Spain. Manufactured in Mexico.

INDICATIONS & USAGE

HOW SUPPLIED

Product: 76413-317

NDC: 76413-317-30 10 TABLET, COATED in a BLISTER PACK / 3 in a CARTON

Zantac

INGREDIENTS AND APPEARANCE

ZANTAC 
ranitidine tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76413-317(NDC:0597-0122)
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
magnesium stearate (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
ferric oxide red (UNII: 1K09F3G675)
titanium dioxide (UNII: 15FIX9V2JP)
triacetin (UNII: XHX3C3X673)

Product Characteristics
Color	PINK	Score	no score
Shape	PENTAGON (5 sided)	Size	3mm
Flavor		Imprint Code	Z;75
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76413-317-30	3 in 1 CARTON	12/21/2006
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020520	12/21/2006

Labeler - Central Texas Community Health Centers (079674019)

Establishment
Name	Address	ID/FEI	Business Operations
Travis County Healthcare District		797039398	RELABEL(76413-317) , REPACK(76413-317)