RANITIDINE 75- ranitidine tablet, coated 
Major Pharmaceuticals

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Major Pharmaceuticals Ranitidine 75 Drug Facts

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 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).

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}?

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

Package/Label Principal Display Panel

REGULAR STRENGTH

RANITIDINE 75

Ranitidine Tablets USP, 75 mg

Acid Reducer

PREVENTS AND RELIEVES HEARTBURN associated with acid indigestion and sour stomach

COMPARE TO the active ingredient of ZANTAC® 75

Actual Size

30 Tablets (30 Doses)

ranitidine-75-image

RANITIDINE 75 
ranitidine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6715
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE75 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorPINKScoreno score
ShapeHEXAGON (6 sided)Size8mm
FlavorImprint Code RT
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6715-461 in 1 CARTON09/26/201804/30/2021
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0904-6715-521 in 1 CARTON09/26/201804/30/2021
260 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07619509/26/201804/30/2021
Labeler - Major Pharmaceuticals (191427277)

Revised: 11/2023
 
Major Pharmaceuticals