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Careone Acid Reducer by American Sales Company

Dosage form: tablet
Ingredients: RANITIDINE HYDROCHLORIDE 75mg
Labeler: American Sales Company
NDC Code: 41520-271

American Sales Company Acid Reducer 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
  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • 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

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.

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
  • do not use if printed foil under cap is broken or missing
  • store at 20° - 25°C (68° - 77°F)
  • avoid excessive heat or humidity
  • this product is sugar free

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, diethyl phthalate, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, titanium dioxide.

Questions or comments?

1-800-719-9260

Consumer Information

What you should know about Ranitidine Tablets, USP 75 mg Acid Reducer

Ranitidine Tablets, USP 75 mg

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

What is Ranitidine Tablet 75 mg?

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

Excellent safety record

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

What symptoms does Ranitidine Tablet 75 mg treat and prevent?

Ranitidine Tablet 75 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 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 Tablet 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). Ranitidine Tablets 75 mg should not be given to children under 12 years old unless directed by a doctor.

How does Ranitidine Tablet 75 mg work?

Ranitidine Tablet 75 mg reduces 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

When should I see a doctor?

  • 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
  • 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.

Questions? Call 1-800-719-9260

BOTTLES: Bottle is sealed with printed foil under cap. Do not use if foil is open or torn. Bottle contains desiccant.

BLISTERS: Do not use if the individual blister unit is open or torn.

DISTRIBUTED BY PERRIGO, ALLEGAN, MI 49010

Made in India

27100 00 J2

Principal Display Panel

Compare to the Active Ingredient in Zantac 75®

Ranitidine Tablets, 75 mg

ACID REDUCER

RELIEVES & PREVENTS

Heartburn

Acid Indigestion

Sour Stomach

(# DOSES) {Replace "#" with number of tablets in package}

Acid Reducer Carton Image 1

Acid Reducer Carton Image 2

Acid Reducer Carton Image 3

CAREONE ACID REDUCER 
ranitidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-271
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE75 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
DIETHYL PHTHALATE 
HYPROMELLOSES 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
TITANIUM DIOXIDE 
Product Characteristics
ColorPINKScoreno score
ShapeHEXAGON (6 sided)Size8mm
FlavorImprint CodeW75
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-271-521 BOTTLE (BOTTLE) in 1 CARTON
110 TABLET (TABLET) in 1 BOTTLE
2NDC:41520-271-391 BOTTLE (BOTTLE) in 1 CARTON
230 TABLET (TABLET) in 1 BOTTLE
3NDC:41520-271-721 BOTTLE (BOTTLE) in 1 CARTON
360 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07676005/29/2009
Labeler - American Sales Company (809183973)

Revised: 02/2012
 
American Sales Company

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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