Pepcid ®

Pepcid ®
SPL v24
SPL
SPL Set ID e874118f-b4fe-4c80-aece-99ea20e7e805
Route
ORAL
Published
Effective Date 2021-01-22
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 Cellulose Acetate Crospovidone Dextrose, Unspecified Form Fd&c Blue No. 1 Aluminum Lake Aluminum Oxide Fd&c Red No. 40 D&c Red No. 7 Acacia Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Lactose Monohydrate Magnesium Stearate Maltodextrin Mineral Oil Sucralose

Identifiers & Packaging

Pill Appearance
Imprint: P Shape: round Color: purple Size: 18 mm Score: 1
Marketing Status
NDA Active Since 2009-03-01

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
  • 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 "Sealed For Your Safety" is broken or missing
Inactive Ingredients

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

*may contain mineral oil

Questions Or Comments?

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

Principal Display Panel

NDC 16837-298-25

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

Berry Flavor

actual size

25 Chewable Tablets

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

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
  • 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 "Sealed For Your Safety" is broken or missing
Inactive Ingredients (Inactive ingredients)

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

*may contain mineral oil

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 16837-298-25

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

Berry Flavor

actual size

25 Chewable Tablets

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)