Pepcid Complete

Pepcid Complete
SPL v4
SPL
SPL Set ID 39f7ee67-4eab-42b0-82fc-40dc8ce7666b
Route
ORAL
Published
Effective Date 2020-09-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carbonate Ion (800 mg) Hydroxide Ion (165 mg) Famotidine (10 mg)
Inactive Ingredients
Cellulose Acetate Starch, Corn Crospovidone (15 Mpa.s At 5%) Dextrose, Unspecified Form Fd&c Blue No. 1 Aluminum Lake Fd&c Red No. 40 Methyl Salicylate 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 2020-09-01

Description

Famotidine 10 mg  Calcium carbonate 800 mg  Magnesium hydroxide 165 mg

Purpose

Acid reducer Antacid


Medication Information

Purpose

Acid reducer Antacid

Description

Famotidine 10 mg  Calcium carbonate 800 mg  Magnesium hydroxide 165 mg

Use

relieves heartburn associated with acid indigestion and sour stomach

Purposes

Acid reducer

Antacid

Warnings

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

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
Drug Facts

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. 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?

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
Package Labeling:50269 016 01

Package Labeling:50269 016 02

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)

Package Labeling:inner Package3

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
Active Ingredients (in Each Chewable Tablet)

Famotidine 10 mg 

Calcium carbonate 800 mg 

Magnesium hydroxide 165 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug. Antacids and acid reducers may interact with certain prescription drugs.


Structured Label Content

Use

relieves heartburn associated with acid indigestion and sour stomach

Purposes

Acid reducer

Antacid

Warnings

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

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
Drug Facts

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. 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?)

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
Package Labeling:50269 016 01 (Package Labeling:50269-016-01)

Package Labeling:50269 016 02 (Package Labeling:50269-016-02)

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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)

Package Labeling:inner Package3 (Package Labeling:Inner Package3)

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
Active Ingredients (in Each Chewable Tablet) (Active ingredients (in each chewable tablet))

Famotidine 10 mg 

Calcium carbonate 800 mg 

Magnesium hydroxide 165 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking a prescription drug. Antacids and acid reducers may interact with certain prescription drugs.


Advanced Ingredient Data


Raw Label Data

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