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Acid Reducer

Generic Name: ranitidine
Dosage Form: tablet, film

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

Inactive ingredients

D&C yellow #10 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide, triacetin

Questions or comments?

1-800-719-9260

Consumer Information

What you should know about MAXIMUM STRENGTH Ranitidine Tablets 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.

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 sodium and sugar free.

What symptoms do MAXIMUM STRENGTH Ranitidine Tablets 150 mg relieve 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 and 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.

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.

Allergy alert: Do not use if you are allergic to ranitidine or other Acid Reducers

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

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 healthcare 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)

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.

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

DISTRIBUTED BY

PERRIGO®

ALLEGAN, MI 49010 U.S.A.

:852B4 00 J1

Package/Label Principal Display Panel

Compare to Zantac 150® active ingredient

H E B®

Ranitidine Tablets, 150 mg

Acid Reducer

Maximum Strength

One Tablet Prevents and Relieves:

Heartburn Associated with Acid Indigestion and Sour Stomach

ACTUAL SIZE

65 TABLETS (65 Doses)

GLUTEN FREE

Acid Reducer 
ranitidine tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-507
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
HYPROMELLOSES  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
TITANIUM DIOXIDE  
TRIACETIN  
Product Characteristics
Color BROWN (Beige) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code L852
Contains         
Packaging
# Item Code Package Description
1 NDC:37808-507-09 1 BOTTLE in 1 CARTON
1 65 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091429 11/30/2015
Labeler - H E B (007924756)
Revised: 11/2015
 
H E B



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