FAMILY WELLNESS ACID REDUCER 150- ranitidine tablet, film coated

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

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Active ingredient:
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)
Available from:
Family Dollar Services Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acid reducer
Authorization status:
Abbreviated New Drug Application
Authorization number:
55319-523-62

FAMILY WELLNESS ACID REDUCER 150- ranitidine tablet, film coated

Family Dollar Services Inc

----------

Family Dollar Services, Inc. Acid Reducer 150 Drug Facts

Active ingredient (in each tablet)

Ranitidine 150 mg (as ranitidine hydrochloride 168 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

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

if you have kidney disease, except under the advice and supervision of a doctor

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

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

Other information

Inactive ingredients

FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, natural

and artificial mint flavor, sucralose, titanium dioxide, triacetin

Questions or comments?

1-800-719-9260

Consumer Information

What you should know about MAXIMUM STRENGTH Ranitidine Tablets, 150 mg Acid

Reducer Cool Mint Tablets

(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?

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 individual blister unit is open or torn

store at 20°-25°C (68°-77°F)

avoid excessive heat or humidity

this product is sodium and sugar free

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.

When swallowed, MAXIMUM STRENGTH Ranitidine Tablets, 150 mg release a cooling

sensation in the mouth and throat.

Excellent Safety Record

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

How should I take MAXIMUM STRENGTH Ranitidine Tablets, 150 mg?

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

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.

MAXIMUM STRENGTH Ranitidine Tablets, 150 mg relieve and prevent heartburn associated

with acid indigestion and sour stomach.

Eating or drinking 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.

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 (up to 2 tablets in 24 hours).

Do not chew tablet.

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

When should I see a doctor?

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

: 95051 00 J3

Package/Label Principal Display Panel

COMPARE TO ZANTAC 150® COOL MINT ACTIVE INGREDIENT

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

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).

MAXIMUM STRENGTH

100% SATISFACTION GUARANTEED OR YOUR MONEY BACK

Acid Reducer 150

Ranitidine Tablets, 150 mg

Acid Reducer

PREVENTS & RELIEVES HEARTBURN

associated with acid indigestion and sour stomach

Cool Mint Tablets

Releases a Cooling Sensation in Mouth & Throat

SUGAR FREE

ACTUAL SIZE

24 Tablets (24 Doses)

FAMILY WELLNESS ACID REDUCER 150

ranitidine tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:55319 -523

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

150 mg

Inactive Ingredients

Ingredient Name

Stre ng th

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

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

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

Family Dollar Services Inc

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIACETIN (UNII: XHX3C3X6 73)

Product Characteristics

Color

BLUE

S core

no sco re

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

L9 50

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:55319 -523-6 2

24 in 1 CARTON

0 4/11/20 19

1

1 in 1 BLISTER PACK; 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 9 1429

0 4/11/20 19

Labeler -

Family Dollar Services Inc (024472631)

Revised: 4/2019

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