Pepcid Complete

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each chewable tablet)	Purposes
Famotidine 10 mg	Acid reducer
Calcium carbonate 800 mg	Antacid
Magnesium hydroxide 165 mg	Antacid

Use

INDICATIONS & USAGE SECTION

relieves heartburn associated with acid indigestion and sour stomach

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

Do not use if you are allergic to famotidine or other acid reducers

Do not use

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

• 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - STOP USE SECTION

• your heartburn continues or worsens
• you need to take this product for more than 14 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

• 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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FDA-Initiated Inactive NDC Indexing#

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

• Pepcid Complete
• Famotidine, Calcium Carbonate, and Magnesium Hydroxide
• famotidine
• calcium carbonate
• carbonate ion
• magnesium hydroxide
• hydroxide ion
• STARCH, CORN
• corn syrup
• crospovidone (120 .mu.m)
• dextrose, unspecified form
• FD&C yellow no. 5
• aluminum oxide
• FD&C yellow no. 6
• acacia
• hydroxypropyl cellulose, unspecified
• hypromellose, unspecified
• lactose monohydrate
• magnesium stearate
• maltodextrin
• mineral oil
• sucralose
• triacetin
• cellulose acetate

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

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Source XML

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Orange Book application contexts page 1 of 1 · 1 matching rows.

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Product history page 1 of 2 · 43 observed states.

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Reported adverse events (FAERS/openFDA)#

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