NDC 41167-0265 Dulcolax Soft Chews Mixed Berry

Magnesium Hydroxide

NDC Product Code 41167-0265

NDC CODE: 41167-0265

Proprietary Name: Dulcolax Soft Chews 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: 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used for a short time to treat occasional constipation. It is a laxative (osmotic-type) that is thought to work by drawing water into the intestines, an effect that helps to cause movement of the intestines. This medication is also used to treat symptoms caused by too much stomach acid such as heartburn, upset stomach, or indigestion. It is an antacid that works by lowering the amount of acid in the stomach.

Product Characteristics

PINK (C48328)
Shape: RECTANGLE (C48347)
25 MM
Score: 1

NDC Code Structure

NDC 41167-0265-3

Package Description: 30 TABLET, CHEWABLE in 1 BAG

NDC 41167-0265-6

Package Description: 60 TABLET, CHEWABLE in 1 BAG

NDC Product Information

Dulcolax Soft Chews Mixed Berry with NDC 41167-0265 is a a human over the counter drug product labeled by Chattem, Inc.. The generic name of Dulcolax Soft Chews Mixed Berry is magnesium hydroxide. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Chattem, Inc.

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.

Dulcolax Soft Chews 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 RED NO. 40 (UNII: WZB9127XOA)
  • SUCROSE (UNII: C151H8M554)
  • WATER (UNII: 059QF0KO0R)

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.
  • 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: part334 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 02-23-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Dulcolax Soft Chews 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


Magnesium hydroxide 1200 mg................................................................................................Saline laxative


● for relief of occasional constipation (irregularity)● this product generally produces bowel movement in ½ to 6 hours

Ask A Doctor Before Use If You Have

● kidney disease  ● a magnesium-restricted diet● stomach pain, nausea or vomiting ● noticed a sudden change in bowel habits that lasts over 2 weeks

Ask A Doctor Or Pharmacist Before Use If You Are

Taking a prescription drug. This product may interact with certain prescription drugs.

Stop Use And Ask A Doctor If

● you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition. ● you need to use a laxative for more than 1 week

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.


● drink a full glass (8 oz) of liquid with each dose● dose may be taken as a single daily dose or in divided doses● do not exceed the maximum recommended daily dose in a 24 hour periodadults and children 12 years of age and over

2 to 4 chewschildren 6 to under 12 years of age


1 to 2 chewschildren under 6 years of age


ask a doctor

Other Information

● each chew contains: magnesium 500 mg, sodium 2 mg● store at room temperature 20°-25°C (68°-77°F)

Inactive Ingredients

Corn syrup, FD&C red no. 40, glycerin, hydrogenated coconut oil, lecithin (soy), natural flavor, sucrose, water


Call 1-866-844-2798 or visit www.Dulcolax.com

* Please review the disclaimer below.