Pepcid®

Pepcid®
SPL v1
SPL
SPL Set ID 7f1903e6-e014-4a6e-86e1-38339f893ede
Route
ORAL
Published
Effective Date 2022-04-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Famotidine (10 mg) Carbonate Ion (800 mg) Hydroxide Ion (165 mg)
Inactive Ingredients
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

Identifiers & Packaging

Pill Appearance
Imprint: P Shape: round Color: yellow Size: 17 mm Score: 1
Marketing Status
NDA Active Since 2009-01-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Use

relieves heartburn associated with acid indigestion and sour stomach

Section 42229-5

Drug Facts

Section 50565-1

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)

Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids and acid reducers may interact with certain prescription drugs.

Section 53414-9

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

Section 55105-1
Active ingredients (in each chewable tablet) Purposes
Famotidine 10 mg Acid reducer
Calcium carbonate 800 mg Antacid
Magnesium hydroxide 165 mg Antacid
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
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
Allergy Alert

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

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)

Stop Use and Ask A Doctor If
  • your heartburn continues or worsens
  • you need to take this product for more than 14 days
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
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


Structured Label Content

Use

relieves heartburn associated with acid indigestion and sour stomach

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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)

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids and acid reducers may interact with certain prescription drugs.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in each chewable tablet) Purposes
Famotidine 10 mg Acid reducer
Calcium carbonate 800 mg Antacid
Magnesium hydroxide 165 mg Antacid
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
Do Not Use (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
Allergy Alert (Allergy alert)

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

Other Information (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 (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? (Questions or comments?)

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • your heartburn continues or worsens
  • you need to take this product for more than 14 days
Ask A Doctor Before Use If You Have (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
Principal Display Panel 20 Packet Carton (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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)