NDC 53666-408 Tabcin 500

  1. Labeler Index
  2. Salimex, S.a.
  3. NDC: 53666-408 Tabcin 500

NDC Product Code 53666-408

NDC CODE: 53666-408

Proprietary Name: Tabcin 500 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: 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.

NDC Code Structure

NDC 53666-408-15

Package Description: 150 BOX in 1 CASE > 12 TABLET, EFFERVESCENT in 1 BOX (53666-408-12)

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Tabcin 500 with NDC 53666-408 is a product labeled by Salimex, S.a.. The generic name of Tabcin 500 is . The product's dosage form is and is administered via form.

Labeler Name: Salimex, S.a.

Dosage Form: -

Product Type: 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.

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.
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Product Labeler Information

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

Labeler Name: Salimex, S.a.
Labeler Code: 53666
Start Marketing Date: 08-21-2013 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: 12-31-2017 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: I 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.

Tabcin 500 Product Label Images

Tabcin 500 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)

Acetylsalicylic Acid 500 mgPhenylephrine Bitartrate 8 mgChlorpheniramine maleate 2 mg

Purpose

Acetylsalicylic Acid 500 mg AnalgesicPhenylephrine Bitartrate 8 mg DecongestantChlorpheniramine maleate 2 mg Antihistamine

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Uses For The Relief Of:

  • Heartburn, acid indigestion, and sour stomach when accompanied with headache or body aches and painsupset stomach with headache from overindulgence in food or drinkheadache, body aches, and pain alone

Warnings

  • Reye's syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.Allergy alert: Aspirin may cause a severe allergic reaction which may include:hivesasthma (wheezing)Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.

Directions

  • Fully dissolve 2 tablets in 4 ounces of water before takingadults and children 12 years and over: 2 tablets every 4 hours, or as directed by a doctor do not exceed 8 tablets in 24 hoursadults 60 years and over 2 tablets every 4 hours, or as directed by a doctor do not exceed 4 tablets in 24 hourschildren under 12 years consult a doctorOther informationeach tablet contains: sodium 567 mgstore at room temperature. Avoid excessive heat.Tabcin 500 in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate

Inactive Ingredients

Sodium Bicarbonate

* Please review the disclaimer below.