PEPCID® AC Maximum Strength

PEPCID® AC Maximum Strength

Drug Labeling and Warnings

Drug Details

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PEPCID AC  MAXIMUM STRENGTH- famotidine tablet, film coated 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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PEPCID® AC
Maximum Strength

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. (1-800-222-1222)

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 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

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

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC: 16837-855-14

MAXIMUM STRENGTH

Pepcid®
AC

Famotidine Tablets 20 mg
Acid Reducer

Just One Tablet!
Prevents & Relieves Heartburn
Due to Acid Indigestion

actual size

25 Tablets

PRINCIPAL DISPLAY PANEL
PEPCID AC   MAXIMUM STRENGTH
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 16837-855
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Famotidine (UNII: 5QZO15J2Z8) (Famotidine - UNII:5QZO15J2Z8) Famotidine20 mg
Inactive Ingredients
Ingredient NameStrength
carnauba wax (UNII: R12CBM0EIZ)  
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
magnesium stearate (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
talc (UNII: 7SEV7J4R1U)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeSEMI-CIRCLE (D shaped) Size9mm
FlavorImprint Code PAC;20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 16837-855-051 in 1 CARTON09/01/2003
15 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 16837-855-255 in 1 CARTON09/01/200303/31/2014
25 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC: 16837-855-491 in 1 CARTON09/01/2003
350 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC: 16837-855-501 in 1 CARTON09/01/2003
450 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5NDC: 16837-855-5250 in 1 TRAY09/01/2003
51 in 1 POUCH; Type 0: Not a Combination Product
6NDC: 16837-855-651 in 1 CARTON09/01/2003
665 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
7NDC: 16837-855-671 in 1 CARTON09/01/2003
765 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
8NDC: 16837-855-701 in 1 CARTON09/01/2003
870 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
9NDC: 16837-855-751 in 1 CARTON09/01/2003
975 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
10NDC: 16837-855-801 in 1 CARTON09/01/2003
1080 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
11NDC: 16837-855-851 in 1 CARTON09/01/2003
1185 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
12NDC: 16837-855-091 in 1 PACKAGE09/01/2003
12100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
13NDC: 16837-855-121 in 1 CARTON09/01/2003
13100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
14NDC: 16837-855-131 in 1 POUCH; Type 0: Not a Combination Product09/01/2003
15NDC: 16837-855-145 in 1 CARTON09/01/2003
155 in 1 BLISTER PACK; Type 0: Not a Combination Product
16NDC: 16837-855-151 in 1 CARTON09/01/2003
1635 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
17NDC: 16837-855-171 in 1 CARTON09/01/2003
1765 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
18NDC: 16837-855-181 in 1 CARTON09/01/2003
18100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
19NDC: 16837-855-405 in 1 CARTON09/01/2003
198 in 1 BLISTER PACK; Type 0: Not a Combination Product
20NDC: 16837-855-5112 in 1 CARTON09/01/2003
205 in 1 BLISTER PACK; Type 0: Not a Combination Product
21NDC: 16837-855-161 in 1 CARTON09/01/2003
2150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
22NDC: 16837-855-202 in 1 PACKAGE08/22/2014
22NDC: 16837-855-161 in 1 CARTON
2250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
23NDC: 16837-855-191 in 1 CARTON04/27/2015
238 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02032509/01/2003
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

Revised: 7/2019
 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division


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