Pepcid Complete

Pepcid Complete
SPL v2
SPL
SPL Set ID ac3cd760-4615-117b-e053-2a95a90a8d42
Route
ORAL
Published
Effective Date 2020-08-06
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
Cellulose Acetate Starch, Corn Crospovidone (15 Mpa.s At 5%) Dextrose, Unspecified Form Fd&c Blue No. 1 Aluminum Oxide Fd&c Red No. 40 D&c Red No. 7 Acacia Hydroxypropyl Cellulose (70000 Wamw) 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 2020-08-06

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

Questions Or Comments?

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

Principal Display Panel

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

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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)