Your browser does not support JavaScript! PEPCID AC (FAMOTIDINE) TABLET, CHEWABLE [MCNEIL CONSUMER PHARMACEUTICALS CO.]
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RxNorm Names

PEPCID AC (famotidine) tablet, chewable
[McNeil Consumer Pharmaceuticals Co.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL New Drug Application
Drug Label Sections

Drug Facts

Active ingredient (in each tablet)

Famotidine 20 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.
  • if you have kidney disease, except under the advice and supervision of a 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:
    • do not swallow tablet whole: chew completely
    • to relieve symptoms, chew 1 tablet before swallowing
    • to prevent symptoms, chew 1 tablet before swallowing at any time from 10 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

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

cellulose acetate, crospovidone, D&C red #7 calcium lake, dextrose, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavors, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, sucralose

Questions or comments?

1-800-755-4008 (English) or 1-888-466-8746 (Spanish)

PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

NDC 16837-854-25

Pepcid® AC

Famotidine Tablets 20 mg
Acid Reducer

EZ CHEWS
Can take without water!

Just One Tablet!

Prevents & Relieves Heartburn
Due to Acid Indigestion

25
Berries 'n' Cream Flavor
Chewable Tablets

PRINCIPAL DISPLAY PANEL
PEPCID AC 
famotidine tablet, chewable
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:16837-854
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Famotidine (Famotidine) Famotidine20 mg
Inactive Ingredients
Ingredient NameStrength
cellulose acetate 
crospovidone 
dextrose 
FD&C blue NO. 1 
aluminum oxide 
FD&C red NO. 40 
hydroxypropyl cellulose (type E) 
hypromelloses 
lactose 
magnesium stearate 
sucralose 
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize12mm
FlavorBERRY (Berries 'n' Cream) Imprint Code PAC;20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16837-854-021 in 1 POUCH
2NDC:16837-854-088 in 1 CARTON
2NDC:16837-854-021 in 1 POUCH
3NDC:16837-854-042 in 1 PACKAGE
3NDC:16837-854-501 in 1 CARTON
350 in 1 BOTTLE
4NDC:16837-854-251 in 1 CARTON
425 in 1 BOTTLE
5NDC:16837-854-351 in 1 CARTON
535 in 1 BOTTLE
6NDC:16837-854-651 in 1 CARTON
665 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02080102/01/2008
Labeler - McNeil Consumer Pharmaceuticals Co. (160159638)

Revised: 10/2012
 
McNeil Consumer Pharmaceuticals Co.

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