APTIDINE 75- ranitidine hydrochloride tablet

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

RANITIDINE HYDROCHLORIDE

PURPOSE

Acid reducer

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & 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

DOSAGE & 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

INACTIVE INGREDIENT

CELLULOSE, MICROCRYSTALLINE

INACTIVE INGREDIENT

STARCH, CORN

INACTIVE INGREDIENT

POVIDONE K30

INACTIVE INGREDIENT

METHYLPARABEN

INACTIVE INGREDIENT

MAGNESIUM STEARATE

INACTIVE INGREDIENT

TALC

INACTIVE INGREDIENT

SODIUM STARCH GLYCOLATE TYPE A POTATO

INACTIVE INGREDIENT

SILICON DIOXIDE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

APTIDINE  75
ranitidine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46084-031
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)	80 mg
STARCH, CORN (UNII: O8232NY3SJ)	30 mg
POVIDONE K30 (UNII: U725QWY32X)	10 mg
METHYLPARABEN (UNII: A2I8C7HI9T)	3 mg
MAGNESIUM STEARATE (UNII: 70097M6I30)	20 mg
TALC (UNII: 7SEV7J4R1U)	30 mg
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)	40 mg
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	1 mg

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	75MG
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46084-031-15	120 in 1 BLISTER PACK
2	NDC: 46084-031-14	60 in 1 BLISTER PACK
3	NDC: 46084-031-13	36 in 1 BLISTER PACK
4	NDC: 46084-031-12	12 in 1 BLISTER PACK
5	NDC: 46084-031-11	5 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075132	03/01/2013

Labeler - A P J Laboratories Limited (677378339)

Registrant - A P J Laboratories Limited (677378339)

Establishment
Name	Address	ID/FEI	Business Operations
A P J Laboratories Limited		677378339	manufacture(46084-031)