REGULAR STRENGTHRanitidine Tablets USP, 75 mg

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 75 MG- ranitidine tablet, film coated 
Vivimed Labs Limited

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REGULAR STRENGTH
Ranitidine Tablets USP, 75 mg

Drug Facts

Active ingredient (in each tablet)

Ranitidine 75 mg (as ranitidine hydrochloride USP, 84 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 withlightheadedness, 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 or torn (bottles)
  • do not use if individual blister unit is open or torn (blisters)
  • store at 20º to 25ºC (68º to 77ºF)
  • avoid excessive heat or humidity
  • this product is sodium and sugar free

Inactive ingredients

colloidal silicon dioxide, ferric oxide red, ferric oxide yellow, 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

  • Do not lie flat or bend over soon after eating
  • Do not eat late at night, or just before bedtime
  • Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
  • Eat slowly and do not eat big meals
  • If you are overweight, lose weight
  • If you smoke, quit smoking
  • Raise the head of your bed
  • Wear loose fitting clothing around your stomach

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 62980-511-01

REGULAR STRENGTH

Ranitidine Tablets, USP

75 mg

ACID REDUCER

PREVENTS & RELIEVES HEARTBURN associated with acid indigestion and sour stomach

30 film coated tablets

Vivimed

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

75 mg 30 carton

NDC 62980-511-02

REGULAR STRENGTHRanitidine Tablets, USP

75 mg

ACID REDUCER

PREVENTS & RELIEVES HEARTBURN associated with acid indigestion and sour stomach

500 film coated tablets

Vivimed

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

75 mg 500s

NDC 62980-511-04

REGULAR STRENGTH

Ranitidine Tablets, USP

75 mg

ACID REDUCER

PREVENTS & RELIEVES HEARTBURN associated with acid indigestion and sour stomach

28 film-coated tablets (4x7's blister pack)

Vivimed

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

75 mg blister
RANITIDINE  75 MG
ranitidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 62980-511
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)  
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)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorPINK (peach to light peach) Scoreno score
ShapePENTAGON (5 SIDED)Size8mm
FlavorImprint Code V;30
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62980-511-021 in 1 CARTON03/08/201811/26/2019
1500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC: 62980-511-044 in 1 CARTON03/08/201811/26/2019
2NDC: 62980-511-037 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC: 62980-511-011 in 1 CARTON03/08/201811/26/2019
330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20916003/08/201811/26/2019
Labeler - Vivimed Labs Limited (650210664)
Registrant - Strides Pharma Global Pte. Ltd. (659220961)
Establishment
NameAddressID/FEIBusiness Operations
Vivimed Life Sciences Private Limited860477684ANALYSIS(62980-511) , MANUFACTURE(62980-511)

Revised: 11/2019
 

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