Ranitidine 150: Package Insert and Label Information

RANITIDINE 150- ranitidine hydrochloride tablet, coated
Marc Glassman, Inc.

Active ingredients (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 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 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,

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

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

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

Inactive ingredients

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

Principal Display Panel

NDC 68998-397-93

*Compare to the Active Ingredient in Zantac150®

Marc’s (logo)

maximum strength

Acid Reducer 150

RANITIDINE 150 mg

Relieves & Prevents Heartburn

(pill image)

24 Tablets

Acid Reducer 150
(click image for full-size original)

Acid Reducer 150

RANITIDINE 150
ranitidine hcl tablets 150mg tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68998-397
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE 150 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 1000
POLYVINYL ALCOHOL (100000 MW)
TITANIUM DIOXIDE
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 9mm
Flavor Imprint Code G;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68998-397-93 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 12 TABLET, COATED in 1 BLISTER PACK This package is contained within the CARTON (68998-397-93)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078192 10/01/2018
Labeler — Marc Glassman, Inc. (094487477)

Revised: 09/2019 Marc Glassman, Inc.

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