NDC 50269-016 Pepcid Complete

Famotidine, Calcium Carbonate, Magnesium Hydroxide

NDC Product Code 50269-016

NDC CODE: 50269-016

Proprietary Name: Pepcid Complete What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Famotidine, Calcium Carbonate, Magnesium Hydroxide What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
PURPLE (C48327)
Shape: ROUND (C48348)
Size(s):
18 MM
Imprint(s):
P
Score: 1

NDC Code Structure

NDC 50269-016-01

Package Description: 6 BLISTER PACK in 1 BOX > 1 TABLET in 1 BLISTER PACK

NDC 50269-016-02

Package Description: 6 BLISTER PACK in 1 BOX > 2 TABLET in 1 BLISTER PACK

NDC 50269-016-25

Package Description: 25 POUCH in 1 BOX > 1 TABLET in 1 POUCH

NDC Product Information

Pepcid Complete with NDC 50269-016 is a a human over the counter drug product labeled by Jc World Bell Wholesale Co., Inc.. The generic name of Pepcid Complete is famotidine, calcium carbonate, magnesium hydroxide. The product's dosage form is tablet and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 283641 and 688892.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Pepcid Complete Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CELLULOSE ACETATE (UNII: 3J2P07GVB6)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
  • DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
  • FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • ACACIA (UNII: 5C5403N26O)
  • HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Jc World Bell Wholesale Co., Inc.
Labeler Code: 50269
FDA Application Number: NDA020958 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-01-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Information for Patients

Calcium Carbonate

Calcium Carbonate is pronounced as (kal' see um) (kar' bon ate)

Why is calcium carbonate medication prescribed?
Calcium carbonate is a dietary supplement used when the amount of calcium taken in the diet is not enough. Calcium is needed by the body for healthy bones, muscles, nervo...
[Read More]
Famotidine

Famotidine is pronounced as (fa moe' ti deen)
Why is famotidine medication prescribed?
Prescription famotidine is used to treat ulcers (sores on the lining of the stomach or small intestine); gastroesophageal reflux disease (GERD, a condition in which backw...
[Read More]
Magnesium Hydroxide

Magnesium Hydroxide is pronounced as (mag nee' zee um) (hye drox' ide)
Why is magnesium hydroxide medication prescribed?
Magnesium hydroxide is used to treat occasional constipation in children and adults on a short-term basis. Magnesium hydroxide is in a class of medications called saline...
[Read More]

* Please review the disclaimer below.

Pepcid Complete Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients (In Each Chewable Tablet)

Famotidine 10 mg 


Calcium carbonate 800 mg 


Magnesium hydroxide 165 mg

Purposes

Acid reducerAntacid

Use

Relieves heartburn associated with acid indigestion and sour stomach

Warnings

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

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 dizzinesschest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadednessfrequent
  • Chest painfrequent wheezing, particularly with heartburnunexplained weight lossnausea or vomitingstomach painkidney 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.

Stop Use And Ask A Doctor If

  • Your heartburn continues or worsensyou 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)

Directions

  • Adults and children 12 years and over:do not swallow tablet whole: chew completelyto relieve symptoms,
  • Chew 1 tablet before swallowing
  • Do not use more than 2 chewable tablets in 24 hourschildren under 12 years: ask a doctor

Other Information

  • Each tablet contains: calcium 320 mg, magnesium 70 mg
  • Read the directions and warnings before usekeep the carton. It contains important information. store at 20°-25°C (68°-77°F)protect from moisturedo 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

* Please review the disclaimer below.