PEPCID AC MAXIMUM STRENGTH- famotidine tablet, film coated

PEPCID AC by

Drug Labeling and Warnings

PEPCID AC by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.
• 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
• kidney disease

Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers 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:
  • 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

See New Warnings

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

INGREDIENTS AND APPEARANCE

PEPCID AC   MAXIMUM STRENGTH
famotidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16837-855
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Famotidine (UNII: 5QZO15J2Z8) (Famotidine - UNII:5QZO15J2Z8)	Famotidine	20 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score	no score
Shape	SEMI-CIRCLE (D shaped)	Size	9mm
Flavor		Imprint Code	PAC;20
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16837-855-05	1 in 1 CARTON	09/01/2003
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 16837-855-25	5 in 1 CARTON	09/01/2003	03/31/2014
2		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 16837-855-49	1 in 1 CARTON	09/01/2003
3		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC: 16837-855-50	1 in 1 CARTON	09/01/2003
4		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5	NDC: 16837-855-52	50 in 1 TRAY	09/01/2003
5		1 in 1 POUCH; Type 0: Not a Combination Product
6	NDC: 16837-855-65	1 in 1 CARTON	09/01/2003
6		65 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
7	NDC: 16837-855-67	1 in 1 CARTON	09/01/2003
7		65 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
8	NDC: 16837-855-70	1 in 1 CARTON	09/01/2003
8		70 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
9	NDC: 16837-855-75	1 in 1 CARTON	09/01/2003
9		75 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
10	NDC: 16837-855-80	1 in 1 CARTON	09/01/2003
10		80 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
11	NDC: 16837-855-85	1 in 1 CARTON	09/01/2003
11		85 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
12	NDC: 16837-855-09	1 in 1 PACKAGE	09/01/2003
12		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
13	NDC: 16837-855-12	1 in 1 CARTON	09/01/2003
13		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
14	NDC: 16837-855-13	1 in 1 POUCH; Type 0: Not a Combination Product	09/01/2003
15	NDC: 16837-855-14	5 in 1 CARTON	09/01/2003
15		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
16	NDC: 16837-855-15	1 in 1 CARTON	09/01/2003
16		35 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
17	NDC: 16837-855-17	1 in 1 CARTON	09/01/2003
17		65 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
18	NDC: 16837-855-18	1 in 1 CARTON	09/01/2003
18		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
19	NDC: 16837-855-40	5 in 1 CARTON	09/01/2003
19		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
20	NDC: 16837-855-51	12 in 1 CARTON	09/01/2003
20		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
21	NDC: 16837-855-16	1 in 1 CARTON	09/01/2003
21		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
22	NDC: 16837-855-20	2 in 1 PACKAGE	08/22/2014
22	NDC: 16837-855-16	1 in 1 CARTON
22		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
23	NDC: 16837-855-19	1 in 1 CARTON	04/27/2015
23		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020325	09/01/2003

Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)