Leader acid reducer complete tablet, chewable

Active ingredients (in each chewable tablet)

Famotidine 10 mg

Calcium carbonate 800 mg

Magnesium hydroxide 165 mg

Purpose

Acid reducer

Antacid

Use

relieves heartburn associated with acid indigestion and sour stomach

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

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug. Antacids may interact with certain prescription drugs.

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:
  • do not swallow tablet whole: chew completely
  • to relieve symptoms, chew 1 tablet before swallowing
  • do not use more than 2 chewable tablets in 24 hours
  • children under 12 years: ask a doctor

Other information

  • each tablet contains: calcium 330 mg; magnesium 70 mg
  • Phenylketonurics: Contains phenylalanine 2.2 mg per tablet
  • read the directions and warnings before use
  • read the bottle label. It contains important information.
  • store at 20-25C (68-77F)
  • protect from moisture

Inactive ingredients

anhydrous lactose, aspartame, dextrates, ferric oxide, glyceryl monostearate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, natural peppermint flavor, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc

Questions or comments?

1-800-719-9260

Ingredients and appearance - Product information

Leader acid reducer complete tablet, chewable- Famotidine, calcium carbonate, magnesium hydroxide

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 37205-681
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Famotidine ( UNII: 5QZO15J2Z8)( Famotidine - UNII: 5QZO15J2Z8 ) 10 mgin 1
Calcium carbonate ( UNII: H0G9379FGK)( Carbonate ion - UNII: 7UJQ5OPE7D ) 800 mgin 1
Magnesium hydroxide ( UNII: NBZ3QY004S)( Magnesium cation - UNII: T6V3LHY838 ) 165 mgin 1

Inactive Ingredients

Ingredient Name Code
Anhydrous lactose ( UNII: 3SY5LH9PMK)
Aspartame ( UNII: Z0H242BBR1)
Dextrates ( UNII: G263MI44RU)
Ferric oxide red ( UNII: 1K09F3G675)
Glyceryl monostearate ( UNII: 230OU9XXE4)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Povidone ( UNII: FZ989GH94E)
Talc ( UNII: 7SEV7J4R1U)

Product Characteristics

Color ORANGE (PEACH WITH WHITE SPECKLES) Size 18 mm
Shape ROUND Score 1
Imprint Code L546 Flavor MINT

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA077355 USA

Labeler - Cardinal Health( 097537435)

Principal display panel

Compare to Pepcid Complete® active ingredients

Dual Action

Acid Reducer Complete

Famotidine 10 mg/Calcium Carbonate 800 mg

Magnesium Hydroxide 165 mg Tablets (Chewable)

Acid Reducer + Antacid

Just One Tablet!

Relieves Heartburn Due to Acid Indigestion

Cool Mint Flavor

25 CHEWABLE TABLETS

Actual Size