ACID

Main information

  • Trade name:
  • ACID REDUCER MAXIMUM STRENGTH ranitidine tablet
  • Composition:
  • RANITIDINE 150 mg
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ACID REDUCER MAXIMUM STRENGTH ranitidine tablet
    United States
  • Language:
  • English

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • Abbreviated New Drug Application
  • Last update:
  • 06-11-2017

Summary of Product characteristics: dosage, interactions, side effects

ACID REDUCER MAXIMUM STRENGTH- ranitidine tablet

Meijer Distribution Inc

----------

Meijer Distribution, Inc. Acid Reducer Drug Facts

Active ingredient (in each tablet)

Ranitidine 150 mg (as ranitidine hydrochloride 168 mg)

Purpos e

Acid reducer

Us es

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 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. (1-800-222-1222)

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 printed foil under cap is broken or missing

avoid excessive heat or humidity

store at 20° - 25°C (68° - 77°F)

this product is sugar free

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, diethyl phthalate, FD&C yellow #6 aluminum lake,

hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose and titanium dioxide

Questions or comments?

1-800-719-9260

Consumer Information

What you should know about

MAXIMUM STRENGTH

Ranitidine Tablets USP, 150 mg

Acid Reducer

(Please read all of this information before taking MAXIMUM STRENGTH Ranitidine Tablets 150 mg.

Save this leaflet for future reference.)

What are MAXIMUM STRENGTH Ranitidine Tablets 150 mg?

MAXIMUM STRENGTH Ranitidine Tablets 150 mg contain 150 mg of ranitidine (as ranitidine

hydrochloride, 168 mg), a medicine that doctors have prescribed more than 200 million times

worldwide.

What symptoms do MAXIMUM STRENGTH Ranitidine Tablets 150 mg treat and prevent?

MAXIMUM STRENGTH Ranitidine Tablets 150 mg relieve and prevent heartburn associated with acid

indigestion and sour stomach.

Certain foods or beverages, and even lying down to sleep, can cause heartburn associated with acid

indigestion or sour stomach. It is normal for the stomach to produce acid, especially after consuming

food or beverages. However, acid in the wrong place, such as the esophagus, or too much acid, can

cause burning pain and discomfort.

Excellent safety Record

The ingredient in MAXIMUM STRENGTH Ranitidine Tablets 150 mg, ranitidine, has been

prescribed by doctors for years to treat millions of patients safely and effectively. The active

ingredient in MAXIMUM STRENGTH Ranitidine Tablets 150 mg has been taken safely with many

frequently prescribed medications.

MAXIMUM STRENGTH Ranitidine Tablets 150 mg are sugar free.

How should I take MAXIMUM STRENGTH Ranitidine Tablets 150 mg?

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.

This medicine can be used up to twice daily (do not take more than 2 tablets in 24 hours).

MAXIMUM STRENGTH Ranitidine Tablets 150 mg should not be given to children under 12 years old

unless directed by a doctor.

How do MAXIMUM STRENGTH Ranitidine Tablets 150 mg work?

MAXIMUM STRENGTH Ranitidine Tablets 150 mg reduce the production of stomach acid. This is

what makes MAXIMUM STRENGTH Ranitidine Tablets 150 mg different from antacids, which

neutralize the acid already in your stomach. Antacids do not reduce the production of acid.

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

Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

When should I see a doctor?

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

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 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.

Questions or comments? 1-800-719-9260

BOTTLES: Bottle is sealed with printed foil under cap. Do not use if printed foil is open or torn.

Bottle contains desiccant.

BLISTERS: Do not use if the individual blister unit is open or torn.

DISTRIBUTED BY

PERRIGO®

ALLEGAN, MI 49010 U.S.A.

Made in India

Revision 11/11

Principal Display Panel

Compare to Zantac 150® active ingredient

Ranitidine Tablets 150 mg

Acid Reducer

Maximum Strength

Prevents & Relieves Heartburn

Associated With Acid Indigestion & Sour Stomach

Acid Reducer Carton Imag e 1

Acid Reducer Carton Imag e 2

ACID REDUCER MAXIMUM STRENGTH

ranitidine tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41250 -0 47

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Meijer Distribution Inc

RANITIDINE HYDRO CHLO RIDE (UNII: BK76 46 5IHM) (RANITIDINE - UNII:8 8 4KT10 YB7)

RANITIDINE

150 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

DIETHYL PHTHALATE (UNII: UF0 6 4M0 0 AF)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

Product Characteristics

Color

ORANGE

S core

no sco re

S hap e

HEXAGON (6 sided)

S iz e

11mm

Flavor

Imprint Code

W;741

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:41250 -0 47-0 2

1 in 1 CARTON

1

24 in 1 BOTTLE

2

NDC:41250 -0 47-71

1 in 1 CARTON

2

50 in 1 BOTTLE

3

NDC:41250 -0 47-56

2 in 1 CARTON

3

9 5 in 1 BOTTLE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 78 6 53

0 2/13/20 0 8

Labeler -

Meijer Distribution Inc (006959555)

Revised: 6/2012