BERKLEY AND JENSEN RANITIDINE- ranitidine tablet, film coated

Berkley and Jensen Ranitidine by

Drug Labeling and Warnings

Berkley and Jensen Ranitidine by is a Otc medication manufactured, distributed, or labeled by BJWC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)
• 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

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?

1-800-934-1204

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

: 852B4 00 J2

Package/Label Principal Display Panel

Compare to the active ingredient in Zantac 150®

MAXIMUM STRENGTH

RANITIDINE TABLETS, 150mg

ACID REDUCER

PREVENTS AND RELIEVES HEARTBURN associated with acid indigestion and sour stomach

ACTUAL SIZE

190 TABLETS

(190 DOSES)

INGREDIENTS AND APPEARANCE

BERKLEY AND JENSEN RANITIDINE 
ranitidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68391-852
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
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	BROWN (Pinkish)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	L852
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68391-852-56	2 in 1 CARTON	09/01/2016
1		95 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	ANDA091429	09/01/2016

Labeler - BJWC (159082692)