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Name:Acid Reduceroriginal Strength
Manufacturer:Hyvee Inc
Category:Over-the-counter (OTC) Marketed Drugs


Hy-Vee Acid Reducer Drug Facts

ACID REDUCER ORIGINAL STRENGTH - famotidine tablet 
HyVee Inc

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Hy-Vee Acid Reducer Drug Facts

Active ingredient (in each tablet)

Famotidine 10 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 food and beverages

Warnings

Allergy alert: Do not use if you are allergic to famotidine 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.

Directions

  • adults and children 12 years and over:
  • to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
  • to prevent symptoms, swallow 1 tablet with a glass of water 60 minutes before eating food or drinking beverages that cause heartburn
  • do not use more than 2 tablets in 24 hours
  • children under 12 years: ask a doctor

Other information

  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20°-25°C (68°-77°F)
  • protect from moisture and light

Inactive ingredients

carnauba wax, hypromellose, iron oxides, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polydextrose, polyethylene glycol, talc, titanium dioxide, triacetin

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Original Strength Pepcid® AC active ingredient

Original Strength

Famotidine Tablets, 10 mg

Acid Reducer

Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion

Actual Size

Acid Reducer Carton Image 1

Acid Reducer Carton Image 1

Acid Reducer Carton Image 2

Acid Reducer Carton Image 2


ACID REDUCER  ORIGINAL STRENGTH
famotidine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42507-141
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 10 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX  
HYPROMELLOSES  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
STARCH, CORN  
POLYDEXTROSE  
POLYETHYLENE GLYCOL  
TALC  
TITANIUM DIOXIDE  
TRIACETIN  
FERRIC OXIDE RED  
FERRIC OXIDE YELLOW  
Product Characteristics
Color PINK Score no score
Shape ROUND Size 8mm
Flavor Imprint Code L141
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42507-141-65 3 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 10 TABLET ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (42507-141-65)
2 NDC:42507-141-72 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
2 60 TABLET ( TABLET) in 1 BOTTLE This package is contained within the CARTON (42507-141-72)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075400 10/19/2009

Labeler - HyVee Inc (006925671)

Revised: 10/2009 HyVee Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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