ACID REDUCER- ranitidine tablet 
P & L Development, LLC

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Ranitidine 150 mg

DRUG FACTS

Active ingredient (in each tablet)

Ranitidine 150 mg (as ranitidine hydrochloride 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
  • if you have kidney disease, except under the advice and supervision of a doctor

Ask a doctor before use if you have

  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • 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

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)
  • children under 12 years: ask a doctor

Other information

  • store at 20° - 25°C (68° - 77°F)
  • avoid excessive heat or humidity
  • this product is sugar free

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, diethyl phthalate, FD&C yellow #6, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose and titanium dioxide

Questions or comments?

Call 1-877-753-3935 Monday- Friday 9AM-5PM EST

Principal Display Panel

*Compare to the active ingredient in Zantac 150®

Maximum Strength

Ranitidine Tablets USP, 150 mg

Acid Reducer

Prevents and Relieves:

 Heartburn Associated with Acid Indigestion and Sour Stomach

* This product is not manufactured or distributed by Boehringer Ingekheim Consumer Health Care Products, owner of the registered trademark Zantac 150©

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DO NOT USE IF PRINTED FOIL UNDER BOTTLE CAP IS OPEN OR TORN

Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information.

Distributed by:

PL Developments

200 Hicks street

Westbury, NY 11590

Product Of India

product label

 PL Developments

Ranitidine 150 mg

ACID REDUCER 
ranitidine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59726-127
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE 150 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIETHYL PHTHALATE (UNII: UF064M00AF)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
Color ORANGE Score no score
Shape HEXAGON (6 SIDED) Size 10mm
Flavor Imprint Code W;741
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59726-127-10 1 in 1 BOX 03/25/2013 08/15/2019
1 150 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078653 03/25/2013 08/15/2019
Labeler - P & L Development, LLC (800014821)

Revised: 9/2019
P & L Development, LLC