APTIDINE 75- ranitidine hydrochloride tablet 
A P J Laboratories Limited

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RANITIDINE HYDROCHLORIDE

Acid reducer

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

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

Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

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







CELLULOSE, MICROCRYSTALLINE

STARCH, CORN


POVIDONE K30


METHYLPARABEN


MAGNESIUM STEARATE

TALC


SODIUM STARCH GLYCOLATE TYPE A POTATO


SILICON DIOXIDE

product

APTIDINE  75
ranitidine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46084-031
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE75 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorpinkScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 75MG
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46084-031-15120 in 1 BLISTER PACK
2NDC:46084-031-1460 in 1 BLISTER PACK
3NDC:46084-031-1336 in 1 BLISTER PACK
4NDC:46084-031-1212 in 1 BLISTER PACK
5NDC:46084-031-115 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07513203/01/2013
Labeler - A P J Laboratories Limited (677378339)
Registrant - A P J Laboratories Limited (677378339)
Establishment
NameAddressID/FEIBusiness Operations
A P J Laboratories Limited677378339manufacture(46084-031)

Revised: 2/2013
Document Id: cbc1050f-9b82-4e4c-aa84-78ba062e75b0
Set id: 549c0a03-bce9-4c0f-8f60-e6964f63dce2
Version: 1
Effective Time: 20130221
 
A P J Laboratories Limited