Sunmark acid reducer tablet, coated

Active ingredient (in each tablet)

Ranitidine 75 mg (as ranitidine hydrochloride 84 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

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 printed foil under bottle cap is open or torn
  • 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 Regular Strength Ranitidine Tablets, 75 mg Acid Reducer

(Please read all of this information before taking Ranitidine Tablets, 75 mg. Save this leaflet for future reference.)

What are Ranitidine Tablets, 75 mg?

  • Ranitidine Tablets, 75 mg contain 75 mg of ranitidine (as ranitidine hydrochloride, 84 mg), a medicine that doctors have prescribed more than 200 million times worldwide.
Ranitidine Illustration

Excellent Safety Record

  • Ranitidine Tablets, 75 mg have been used safely and effectively for years as an over-the-counter medication.
  • Ranitidine Tablets, 75 mg are sodium and sugar free.

What symptoms do Ranitidine Tablets, 75 mg relieve and prevent?

  • Ranitidine Tablets, 75 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.

How should I take Ranitidine Tablets, 75 mg?

  • To relievesymptoms, swallow 1 tablet with a glass of water.
  • To preventsymptoms, swallow 1 tablet with a glass of water 30 to 60 minutes beforeeating 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).

  • Do not chew tablet

Ranitidine Tablets, 75 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 Ranitidine Tablets, 75 mg work?

  • Ranitidine Tablets, 75 mg reduce the production of stomach acid. This is what makes Ranitidine Tablets, 75 mg different from antacids, which neutralize the acid already in your stomach. Antacids do not reduce the production of acid.

Additional 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

Clinical studies prove Ranitidine Tablets, 75 mg are effective in relieving and preventing heartburn.

In clinical studies, Ranitidine Tablets, 75 mg were significantly better than placebo pills.

Percent of Heartburn Episodes Relieved

Ranitidine Table 1

Percent of Patients with Prevention or Reduction of Heartburn Symptoms

Ranitidine Table 2

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
  • 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

: 87600 00 J1

Ingredients and appearance - Product information

Sunmark acid reducer tablet, coated- Ranitidine

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 49348-136
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Ranitidine hydrochloride ( UNII: BK76465IHM)( Ranitidine - UNII: 884KT10YB7 ) 75 mgin 1

Inactive Ingredients

Ingredient Name Code
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Fd&c blue no. 2 ( UNII: L06K8R7DQK)
Hypromelloses ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Titanium dioxide ( UNII: 15FIX9V2JP)
Triacetin ( UNII: XHX3C3X673)

Product Characteristics

Color PINK Size 8 mm
Shape HEXAGON (6 sided) Score 1
Imprint Code RT

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076195 USA

Labeler - Strategic Sourcing Services LLC( 116956644)

Package/label principal display panel

COMPARE TO ZANTAC 75® ACTIVE INGREDIENT

Regular Strength

Ranitidine Tablets, 75 mg

acid reducer

PREVENTS AND RELIEVES HEARTBURN associated with acid indigestion and sour stomach

REGULAR STRENGTH

Actual Size

GLUTEN FREE

30 TABLETS (30 DOSES)