RANITIDINE- ranitidine tablet 
AvPAK

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Ranitidine Tablets, USP

ACTIVE INGREDIENT(S)

Ranitidine 150 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
◾  if you have kidney disease, except under the advice and supervision of a doctor

ASK A DOCTOR BEFORE USE IF

◾ 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 DOCTOR IF

◾ your heartburn continues or worsens
◾ you need to take this product for more than 14 days

PREGNANCY/BREASTFEEDING

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.

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 (for cool mint tablets only)
◾ children under 12 years: ask a doctor



OTHER INFORMATION

· safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing

· store between 20°and 25°C (68°and 77°F)

· protect from excessive moisture and light

INACTIVE INGREDIENTS

For 150 mg:croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol,talcum, titanium dioxide

For 150 mg cool mint:acacia, croscarmellose sodium, FD&C Blue No. 1,magnesium stearate, menthol, microcrystalline cellulose,polyethylene glycol, polyvinyl alcohol, talcum,
titanium dioxide

Questions or comments?

Contact 1-855-361-3993

CONSUMER INFORMATION

ranitidineimage.jpg

PRINCIPAL DISPLAY PANEL

150mg

RANITIDINE 
ranitidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50268-721
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE150 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize9mm
FlavorImprint Code 150;G
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50268-721-1550 in 1 BOX05/17/2019
1NDC:50268-721-111 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21024305/17/2019
Labeler - AvPAK (832926666)

Revised: 5/2019
Document Id: 89175238-3add-22cd-e053-2a95a90ad3f0
Set id: 891713fa-e572-371c-e053-2995a90ae88d
Version: 1
Effective Time: 20190517
 
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