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 Johnson & Johnson Consumer Inc.. 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
• read the bottle. It contains important information.
• store at 20°-25°C (68°-77°F)
• protect from moisture
• do not use if foil inner seal imprinted with "SAFETY SEAL®" is broken or missing

Inactive ingredients

cellulose acetate, corn starch, crospovidone, D&C yellow no. 10 aluminum lake, dextrose excipient, FD&C blue no. 1 aluminum lake, flavors, gum arabic, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, mineral oil, sucralose

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

See New Warnings

NDC: 16837-891-50

DUAL ACTION
Pepcid®
Complete

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

Just One Tablet!
Relieves Heartburn Due to Acid Indigestion
Cool Mint Flavor

50
Chewable Tablets

actual size

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16837-891
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
cellulose acetate (UNII: 3J2P07GVB6)
starch, corn (UNII: O8232NY3SJ)
crospovidone (15 MPA.S AT 5%) (UNII: 68401960MK)
D&C yellow no. 10 (UNII: 35SW5USQ3G)
aluminum oxide (UNII: LMI26O6933)
Dextrose, Unspecified form (UNII: IY9XDZ35W2)
FD&C blue no. 1 (UNII: H3R47K3TBD)
acacia (UNII: 5C5403N26O)
Hydroxypropyl Cellulose (70000 WAMW) (UNII: 66O7AQV0RT)
hypromellose, unspecified (UNII: 3NXW29V3WO)
lactose monohydrate (UNII: EWQ57Q8I5X)
magnesium stearate (UNII: 70097M6I30)
maltodextrin (UNII: 7CVR7L4A2D)
mineral oil (UNII: T5L8T28FGP)
sucralose (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	GREEN	Score	no score
Shape	ROUND	Size	18mm
Flavor	MINT	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16837-891-25	25 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2009
2	NDC: 16837-891-50	50 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020958	03/01/2009

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