PEPCID COMPLETE- famotidine, calcium carbonate, and magnesium hydroxide tablet, chewable

Pepcid Complete by

Drug Labeling and Warnings

Pepcid Complete by is a Otc medication manufactured, distributed, or labeled by Select Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each chewable tablet)	Purposes
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
• kidney disease

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

Other information

• each tablet contains: calcium 320 mg; magnesium 70 mg
• 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
• do not use if pouch is torn or damaged

Inactive ingredients

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

Questions or comments?

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

SPL UNCLASSIFIED SECTION

Repackaged and distributed by:
Select Corporation 1433 Wainwright Way,
Carrollton, TX 75007, 877-244-4400, M-F 9am-5pm,
from a product manufactured by
JOHNSON & JOHNSON CONSUMER INC.

Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
McNeil Consumer Healthcare Division
Fort Washington, PA 19034 USA

PRINCIPAL DISPLAY PANEL - 20 Packet Carton

DUAL ACTION
Pepcid®
Complete®
Acid Reducer + Antacid

Famotidine 10mg–Acid reducer
Calcium carbonate 800mg–Antacid
Magnesium hydroxide 165mg–Antacid

Just One Tablet!
Relieves Heartburn Due
to Acid Indigestion

Berry Flavor

20
Packets of
1 Chewable
Tablet

INGREDIENTS AND APPEARANCE

PEPCID COMPLETE 
famotidine, calcium carbonate, and magnesium hydroxide tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52904-948(NDC:16837-246)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
famotidine (UNII: 5QZO15J2Z8) (famotidine - UNII:5QZO15J2Z8)	famotidine	10 mg
calcium carbonate (UNII: H0G9379FGK) (carbonate ion - UNII:7UJQ5OPE7D)	calcium carbonate	800 mg
magnesium hydroxide (UNII: NBZ3QY004S) (hydroxide ion - UNII:9159UV381P)	magnesium hydroxide	165 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
corn syrup (UNII: 9G5L16BK6N)
crospovidone (120 .mu.m) (UNII: 68401960MK)
dextrose, unspecified form (UNII: IY9XDZ35W2)
FD&C yellow no. 5 (UNII: I753WB2F1M)
aluminum oxide (UNII: LMI26O6933)
FD&C yellow no. 6 (UNII: H77VEI93A8)
acacia (UNII: 5C5403N26O)
hydroxypropyl cellulose, unspecified (UNII: 9XZ8H6N6OH)
hypromellose, unspecified (UNII: 3NXW29V3WO)
lactose monohydrate (UNII: EWQ57Q8I5X)
magnesium stearate (UNII: 70097M6I30)
maltodextrin (UNII: 7CVR7L4A2D)
mineral oil (UNII: T5L8T28FGP)
sucralose (UNII: 96K6UQ3ZD4)
triacetin (UNII: XHX3C3X673)
cellulose acetate (UNII: 3J2P07GVB6)

Product Characteristics
Color	YELLOW	Score	no score
Shape	ROUND	Size	17mm
Flavor	FRUIT (tropical fruit flavor)	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52904-948-03	1 in 1 BLISTER PACK	01/01/2009
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 52904-948-07	2 in 1 BLISTER PACK	01/01/2009
2		1 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 52904-948-20	20 in 1 CARTON	01/01/2009
3		1 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 52904-948-25	25 in 1 CARTON	01/01/2009
4		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020958	01/01/2009

Labeler - Select Corporation (053805599)