NDC 41167-1040 Rolaids Advanced Antacid Anti-gas Mixed Berry

Calcium Carbonate And Magnesium Hydroxide And Simethicone

NDC Product Code 41167-1040

NDC CODE: 41167-1040

Proprietary Name: Rolaids Advanced Antacid Anti-gas Mixed Berry 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: Calcium Carbonate And Magnesium Hydroxide And Simethicone 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):
PINK (C48328 - ASSORTED COLORS)
BLUE (C48333 - ASSORTED COLORS)
PURPLE (C48327 - ASSORTED COLORS)
Shape: ROUND (C48348)
Size(s):
20 MM
Imprint(s):
R;A
Score: 1
Flavor(s):
STRAWBERRY (C73417 - ASSORTED FLAVORS)
GRAPE (C73391 - ASSORTED FLAVORS)
BLUEBERRY (C73367 - ASSORTED FLAVORS)
BERRY (C73365 - ASSORTED FLAVORS)

NDC Code Structure

NDC 41167-1040-0

Package Description: 75 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

NDC 41167-1040-1

Package Description: 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

NDC 41167-1040-2

Package Description: 72 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

NDC 41167-1040-3

Package Description: 3 CELLO PACK in 1 PACKAGE > 10 TABLET, CHEWABLE in 1 CELLO PACK (41167-1040-5)

NDC Product Information

Rolaids Advanced Antacid Anti-gas Mixed Berry with NDC 41167-1040 is a a human over the counter drug product labeled by Chattem, Inc.. The generic name of Rolaids Advanced Antacid Anti-gas Mixed Berry is calcium carbonate and magnesium hydroxide and simethicone. The product's dosage form is tablet, chewable and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1649510.

Dosage Form: Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.

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.

Rolaids Advanced Antacid Anti-gas Mixed Berry 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.

  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • DEXTROSE (UNII: IY9XDZ35W2)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • SUCROSE (UNII: C151H8M554)

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: Chattem, Inc.
Labeler Code: 41167
FDA Application Number: part331 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: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 02-02-2015 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]
Magnesium Hydroxide

Magnesium Hydroxide is pronounced as (mag nee' zee um) (hye drox' ide)
Why is magnesium hydroxide medication prescribed?
Magnesium hydroxide is used on a short-term basis to treat constipation.This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more inf...
[Read More]
Simethicone

Simethicone is pronounced as (sye meth' i kone)
Why is simethicone medication prescribed?
Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating.This medication is sometimes prescribed for other uses;...
[Read More]

* Please review the disclaimer below.

Rolaids Advanced Antacid Anti-gas Mixed Berry 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 tablet)Calcium carbonate USP 1000 mgMagnesium hydroxide USP 200 mgSimethicone USP 40 mg

Purpose

AntacidAntacidAntigas

Use

  • Relieves:heartburnsour stomachacid indigestionupset stomach associated with these symptomspressure and bloating commonly referred to as gas

Ask A Doctor Or Pharmacist Before Use If You Are

Now taking a prescription drug. Antacids may interact with certain prescription drugs.

When Using This Product

  • Do not take more than 7 tablets in a 24-hour perioddo not use the maximum dosage for more than 2 weeks

Directions

  • Chew 2-3 tablets as symptoms occur, or as directed by a doctor

Other Information

  • Each tablet contains: calcium 400 mg, magnesium 85 mg

Inactive Ingredients

Blue 1 lake, blue 2 lake, dextrose, magnesium stearate, maltodextrin, natural and artificial flavors, red 40 lake, silicon dioxide, stearic acid, sucralose, sucrose (309-145)

* Please review the disclaimer below.