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

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Pepcid AC

McNeil Consumer Pharmaceuticals Co.

Original Strength Pepcid AC


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each tablet)

Famotidine 10 mg

Purpose

Acid reducer

Pepcid AC 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 at any time from 15 to 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

Pepcid AC 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

Inactive ingredients

carnauba wax, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, talc, titanium dioxide

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC 16837-872-20

ORIGINAL STRENGTH

Pepcid ®
AC ®

Famotidine Tablets 10 mg
Acid Reducer

Just One Tablet!

Prevents & Relieves Heartburn
Due to Acid Indigestion

30 Tablets

Pepcid AC

Pepcid AC

Famotidine TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:16837-872
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FAMOTIDINE FAMOTIDINE 10 mg

Inactive Ingredients

Ingredient Name Strength
carnauba wax
HYDROXYPROPYL CELLULOSE (TYPE L)
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
ferric oxide red
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
PINK (pale rose) 7 mm PEPCID;AC SQUARE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 6 in 1 BLISTER PACK
2 10 in 1 BLISTER PACK
3 10 in 1 BLISTER PACK
4 10 in 1 BLISTER PACK
5 60 in 1 BOTTLE, PLASTIC
6 90 in 1 BOTTLE, PLASTIC
7 10 in 1 BLISTER PACK
8 10 in 1 BLISTER PACK
9 90 in 1 BOTTLE, PLASTIC
10 NDC:16837-872-22 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020325 1995-10-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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