ACID RELIEF- ranitidine tablet, coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)
Available from:
Meijer Distribution Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acid reducer
Authorization status:
Abbreviated New Drug Application
Authorization number:
41250-252-72

ACID RELIEF- ranitidine tablet, coated

Meijer Distribution Inc

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Meijer Distribution, Inc. Acid Relief Drug Facts

Active ingredient (in each tablet)

Ranitidine 75 mg (as ranitidine hydrochloride 84 mg)

Purpos e

Acid reducer

Us es

Warnings

Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast-feeding,

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

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

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

your heartburn continues or worsens

you need to take this product for more than 14 days

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

Other information

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?

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

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

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.

Excellent Safety Record

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

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?

This medicine can be used up to twice daily (do not take more than 2 tablets in 24 hours).

Ranitidine Tablets, 75 mg should not be given to children under 12 years old unless directed by a

doctor.

How do Ranitidine Tablets, 75 mg work?

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.

Ranitidine Tablets, 75 mg relieve and prevent heartburn associated with acid indigestion and sour

stomach.

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.

Do not chew tablet

Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

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.

Additional tips for managing heartburn

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

Percent of Patients with Prevention or Reduction of Heartburn Symptoms

Antacids do not reduce the production of acid.

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?

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)

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

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

Principal Display Panel

Compare to Zantac 75

active ingredient

REGULAR STRENGTH

acid relief

Ranitidine Tablets, 75 mg

Acid Reducer

PREVENTS & RELIEVES HEARTBURN

associated with acid indigestion and sour stomach

60 Tablets (60 Doses)

actual size

ACID RELIEF

ranitidine tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41250 -252

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

RANITIDINE HYDRO CHLO RIDE (UNII: BK76 46 5IHM) (RANITIDINE - UNII:8 8 4KT10 YB7)

RANITIDINE

75 mg

Inactive Ingredients

Ingredient Name

Stre ng th

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FD&C BLUE NO . 2 (UNII: L0 6 K8 R7DQK)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIACETIN (UNII: XHX3C3X6 73)

Product Characteristics

Color

PINK

S core

no sco re

S hap e

HEXAGON (6 sided)

S iz e

8 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:41250 -252-72

1 in 1 CARTON

0 5/0 2/20 19

1

6 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 76 19 5

0 5/0 2/20 19

Meijer Distribution Inc

Labeler -

Meijer Distribution Inc (006959555)

Revised: 5/2019

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