RANITIDINE HYDROCHLORIDE tablet

ranitidine hydrochloride by

Drug Labeling and Warnings

ranitidine hydrochloride by is a Otc medication manufactured, distributed, or labeled by Gericare Pharmaceuticals, Strides Pharma Global Pte. Ltd., Vivimed Life Sciences Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (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 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

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.
• kidney disease

• Ask a doctor or pharmacist before use if you are
  • taking a prescription drug. Acid reducers may interact with certain prescription drugs

Stop use and ask a doctor if

• your heartburn continues or worsens
• you need to take this product for more than 14 days.

OTC - PREGNANCY OR BREAST FEEDING

ask a health professional before use.

OTC - 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

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

Inactive ingredients

colloidal silicon dioxide, ferric oxide red, glyceryl monostearate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulphate, talc, and titanium dioxide

Questions?

call 1-800-540-3765

Manufactured in INDIA for:

Gericare Pharmaceuticals,

1650 63 Street, Brooklyn, NY 11204

M.L. No.: TN00002326

Rev. 05/2019

Consumer Information Leaflet

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 USP, 150 mg. Save this leaflet for future reference.)

What are MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg?

• MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg contains 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 USP, 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 USP, 150 mg has been taken safely with many frequently prescribed medications.
• MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg are sodium and sugar free.

What symptoms does MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg relieve and prevent?

• MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg relieves and prevents 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 USP, 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 USP, 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 USP, 150 mg work?

• MAXIMUM STRENGTH      Ranitidine Tablets USP, 150 mg reduces the production of stomach acid.      This is what makes MAXIMUM STRENGTH Ranitidine Tablets USP, 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

• 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
  • kidney disease
• Ask a doctor or pharmacist before use if you are
  • taking a prescription drug. Acid reducers may interact with certain prescription drugs
• 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? call at 1-800-540-3765

Manufactured by:

Vivimed Life Sciences Private Limited,

Plot No. 101, 102, 107 & 108,

SIDCO Pharmaceutical Complex, Alathur,

Kanchipuram – 603 110, Tamilnadu, India.

Distributed by:

Gericare Pharmaceuticals,

1650 63 Street, Brooklyn, NY 11204

Rev. 05/2019       

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 57896-713-50

MAXIMUM STRENGTH

Ranitidine Tablets, USP

150 mg

ACID REDUCER

PREVENTS & RELIEVES HEARTBURN associated with acid indigestion and sour stomach

5000 tablets

Gericare

INGREDIENTS AND APPEARANCE

RANITIDINE HYDROCHLORIDE 
ranitidine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57896-713
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	PINK (pink to light pink)	Score	no score
Shape	PENTAGON (5 SIDED)	Size	10mm
Flavor		Imprint Code	V;31
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57896-713-50	5000 in 1 BAG; Type 0: Not a Combination Product	08/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209161	08/02/2019

Labeler - Gericare Pharmaceuticals (611196254)

Registrant - Strides Pharma Global Pte. Ltd. (659220961)

Establishment
Name	Address	ID/FEI	Business Operations
Vivimed Life Sciences Private Limited		860477684	ANALYSIS(57896-713) , MANUFACTURE(57896-713)