Pepcid Complete- Famotidine, Calcium Carbonate, Magnesium Hydroxide Chewable Tablet Tablet, Chewable

Pepcid Complete- Famotidine, Calcium Carbonate, Magnesium Hydroxide Chewable Tablet Tablet, Chewable
SPL v4
SPL
SPL Set ID f3cf2e19-1348-0eac-e053-2a95a90a46c1
Route
ORAL
Published
Effective Date 2023-02-06
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
Hydroxypropyl Cellulose, Unspecified Magnesium Stearate Sucralose Dextrose, Unspecified Form Fd&c Blue No. 1 Aluminum Lake Fd&c Red No. 40 Mineral Oil Starch, Corn D&c Red No. 7 Acacia Hypromellose, Unspecified Lactose Monohydrate Aluminum Oxide Cellulose Acetate Crospovidone Maltodextrin

Identifiers & Packaging

Pill Appearance
Imprint: P Shape: round Color: purple Size: 18 mm Score: 1
Marketing Status
NDA Active Since 2020-07-29

Description

Famotidine 10 mg Calcium carbonate 800 mg Magnesium hydroxide 165 mg

Purpose

Acid reducer Antacid Antacid


Medication Information

Purpose

Acid reducer

Antacid

Antacid

Description

Famotidine 10 mg Calcium carbonate 800 mg Magnesium hydroxide 165 mg

Use
  • relieves heartburn associated with acid indigestion and sour stomach
Section 42229-5

Distributed by: JOHNSON & JOHNSON CONSUMER INC.

McNeil Consumer Healthcare Division, Fort Washington, PA 19034 USA

©McNeil Consumer Pharmaceuticals Co. 2022 US Patent Nos. 6,814,978

Repackaged with permission of manufacturer by:

Lil’ Drug Store Products, Inc., Cedar Rapids, IA 52404

Distributed by: Consumer Value Products, Inc., Temple, TX 76502

www.CVPproducts.com

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
Allergy Alert:

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

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
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
Cvp 2 Count Carton

DUAL ACTION

Pepcid ®

Complete

Famotidine 10mg - Acid Reducer

Calcium carbonate 800mg - Antacid

Magnesium Hydroxide 165mg - Antacid

Just One Tablet!

Relieves Heartburn Due

to Acid Indigestion

Berry Flavor

2

Chewable

CVP

HEALTH

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
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)

Active Ingredient (in Each Tablet)

Famotidine 10 mg

Calcium carbonate 800 mg

Magnesium hydroxide 165 mg

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
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
Section 42229-5 (42229-5)

Distributed by: JOHNSON & JOHNSON CONSUMER INC.

McNeil Consumer Healthcare Division, Fort Washington, PA 19034 USA

©McNeil Consumer Pharmaceuticals Co. 2022 US Patent Nos. 6,814,978

Repackaged with permission of manufacturer by:

Lil’ Drug Store Products, Inc., Cedar Rapids, IA 52404

Distributed by: Consumer Value Products, Inc., Temple, TX 76502

www.CVPproducts.com

Purpose

Acid reducer

Antacid

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
Allergy Alert: (Allergy alert:)

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

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
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
Cvp 2 Count Carton (CVP 2 Count Carton)

DUAL ACTION

Pepcid ®

Complete

Famotidine 10mg - Acid Reducer

Calcium carbonate 800mg - Antacid

Magnesium Hydroxide 165mg - Antacid

Just One Tablet!

Relieves Heartburn Due

to Acid Indigestion

Berry Flavor

2

Chewable

CVP

HEALTH

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
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)

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Famotidine 10 mg

Calcium carbonate 800 mg

Magnesium hydroxide 165 mg

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
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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