SMART SENSE RANITIDINE- ranitidine tablet, film coated 
Kmart Corporation

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Kmart Corporation Ranitidine Tablets 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

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 (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)
do not chew tablet
children under 12 years: ask a doctor

Other information

do not use if individual blister unit is open or torn (Blister Carton)
do not use if printed foil under bottle cap is open or torn. (Bottle Carton or Stretch Card)
store at 20°-25°C (68°-77°F)
avoid excessive heat or humidity
this product is sodium and sugar free

Inactive ingredients

FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, natural and artificial mint flavor, sucralose, 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 Cool Mint Tablets

(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.
When swallowed, MAXIMUM STRENGTH Ranitidine Tablets, 150 mg release a cooling sensation in the mouth and throat.
Esophagus

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.

Eating or drinking 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 (up to 2 tablets in 24 hours).

Do not chew tablet.

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

: 950B5 00 J2

Package/Label Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN ZANTAC 150® COOL MINT TABLETS

ACTUAL SIZE

MAXIMUM STRENGTH

Ranitidine TABLETS 150 mg

ACID REDUCER

PREVENTS & RELIEVES HEARTBURN associated with acid indigestion and sour stomach

COOL MINT TABLETS

Releases a Cooling Sensation in Mouth & Throat

SUGAR FREE

65 TABLETS

(65 DOSES)

Smart Sense Ranitidine image
SMART SENSE RANITIDINE 
ranitidine tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49738-361
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
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code L950
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49738-361-09 1 in 1 CARTON 03/21/2014
1 65 in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:49738-361-62 24 in 1 CARTON 03/21/2014
2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091429 03/21/2014
Labeler - Kmart Corporation (008965873)

Revised: 7/2016
Document Id: 3aaf662a-fc5f-4c9d-ac4e-b5c134d207eb
Set id: b2aee5c7-7e02-496c-bc3d-b60e90d240f0
Version: 2
Effective Time: 20160713
 
Kmart Corporation