MAXIMUM STRENGTHRanitidine Tablets USP, 150mg

Ranitidine by

Drug Labeling and Warnings

Ranitidine by is a Otc medication manufactured, distributed, or labeled by Vivimed Labs Limited, Strides Vivimed Pte. Ltd., Vivimed Life Sciences Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RANITIDINE 150 MG- ranitidine tablet, film coated 
Vivimed Labs Limited

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MAXIMUM STRENGTH
Ranitidine Tablets USP, 150mg

Drug Facts

Active ingredient (in each tablet)

Ranitidine 150 mg (as ranitidine hydrochloride USP, 168 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.

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 is open or torn (bottles)
  • do not use if individual blister unit is open or torn (blisters)
  • store at 20° to 25°C (68° to 77°F)
  • avoid excessive heat or humidity
  • this product is sodium and sugar free

Inactive ingredients

colloidal silicon dioxide, ferric oxide red, glyceryl monostearate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulphate, talc, and titanium dioxide

Questions?

call Vivimed Labs USA at 732-398-0008

Tips for managing heartburn

Read the directions and warning before use. Keep the carton. It contains important information including tips for managing heartburn

Manufactured in INDIA for :

Vivimed Labs USA,

1100 Cornwall Road, Suite 160,

Monmouth Junction, NJ 08852, USA.

Rev. 11/2019

M.L. No.: TN00002326

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62980-512-01

MAXIMUM STRENGTH

Ranitidine Tablets, USP

150 mg

ACID REDUCER

PREVENTS & RELIEVES HEARTBURN associated with acid indigestion and sour stomach

30 tablets

Vivimed

Read the directions and warnings before use. Keep the carton. It contains important information including tips for managing heartburn.

image01

NDC 62980-512-02

MAXIMUM STRENGTH

Ranitidine Tablets, USP

150 mg

ACID REDUCER

PREVENTS & RELIEVES HEARTBURN associated with acid indigestion and sour stomach

500 tablets

Vivimed

Read the directions and warnings before use. Keep the carton. It contains important information including tips for managing heartburn.

image02

NDC 62980-512-04

MAXIMUM STRENGTH

Ranitidine Tablets, USP

150 mg

ACID REDUCER

PREVENTS & RELIEVES HEARTBURN associated with acid indigestion and sour stomach

28 film-coated tablets (4 x 7's Blister pack)

Vivimed

Read the directions and warnings before use. Keep the carton. It contains important information including tips for managing heartburn.

image03
RANITIDINE  150 MG
ranitidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 62980-512
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)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Product Characteristics
ColorPINK (pink to light pink) Scoreno score
ShapePENTAGON (5 SIDED)Size10mm
FlavorImprint Code V;31
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62980-512-011 in 1 CARTON03/08/201811/26/2019
130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC: 62980-512-044 in 1 CARTON03/08/201811/26/2019
2NDC: 62980-512-037 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC: 62980-512-021 in 1 CARTON03/08/201811/26/2019
3500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20916103/08/201811/26/2019
Labeler - Vivimed Labs Limited (650210664)
Registrant - Strides Pharma Global Pte. Ltd. (659220961)
Establishment
NameAddressID/FEIBusiness Operations
Vivimed Life Sciences Private Limited860477684ANALYSIS(62980-512) , MANUFACTURE(62980-512)

Revised: 11/2019
 
Vivimed Labs Limited