Pepcid Complete description, usages, side effects, indications, overdosage, supplying and lots more!

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Pepcid Complete

McNeil Consumer Pharmaceuticals Co.

Pepcid Complete


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each chewable tablet) Purpose
Famotidine 10 mg Acid reducer
Calcium carbonate 800 mg Antacid
Magnesium hydroxide 165 mg 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.

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

Pepcid Complete Other information

  • each tablet contains: calcium 320 mg, magnesium 70 mg
  • read the directions and warnings before use
  • read the bottle. It contains important information.
  • store at 20°-25°C (68°-77°F)
  • protect from moisture
  • do not use if foil seal under bottle cap printed "SAFETY SEAL®" is open or torn

Inactive ingredients

cellulose acetate, corn starch, crospovidone, D&C red no. 7 calcium lake, dextrose excipient, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavors, gum arabic, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, mineral oil, sucralose

Questions or comments?

call 1-800-755-4008 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

NDC 16837-298-50

DUAL ACTION
Pepcid®
Complete®
Acid Reducer + Antacid

Just One Tablet!

Relieves Heartburn
Due to Acid Indigestion

50
Chewable Tablets
Berry Flavor

Pepcid Complete

Pepcid Complete

Famotidine, Calcium carbonate, and Magnesium hydroxide TABLET, CHEWABLE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:16837-298
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FAMOTIDINE FAMOTIDINE 10 mg
CALCIUM CARBONATE 800 mg
magnesium hydroxide MAGNESIUM CATION 165 mg

Inactive Ingredients

Ingredient Name Strength
CELLULOSE ACETATE
STARCH, CORN
CROSPOVIDONE
DEXTROSE
FD&C BLUE NO. 1
ALUMINUM OXIDE
FD&C RED NO. 40
ACACIA
HYDROXYPROPYL CELLULOSE (TYPE E)
HYPROMELLOSES
lactose monohydrate
MAGNESIUM STEARATE
maltodextrin
Mineral Oil
Sucralose

Product Characteristics

Color Size Imprint Code Shape
PURPLE 18 mm P ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:16837-298-12 100 in 1 BOTTLE, PLASTIC
2 NDC:16837-298-25 25 in 1 BOTTLE, PLASTIC
3 NDC:16837-298-36 35 in 1 BOTTLE, PLASTIC
4 NDC:16837-298-50 50 in 1 BOTTLE, PLASTIC
5 NDC:16837-298-64 65 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020958 2009-03-01


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Be sure to consult your doctor before taking any medication!
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