NDC 63102-403 Actidogesic Df

Acetaminophen, Dexbrompheniramine Maleate

NDC Product Information

Actidogesic Df with NDC 63102-403 is a a human over the counter drug product labeled by Actipharma, Inc. The generic name of Actidogesic Df is acetaminophen, dexbrompheniramine maleate. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Actipharma, Inc

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.

Actidogesic Df 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.

  • ACETAMINOPHEN 500 mg/1
  • DEXBROMPHENIRAMINE MALEATE 1 mg/1

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.

  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

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: Actipharma, Inc
Labeler Code: 63102
FDA Application Number: part341 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: 07-10-2020 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.

Actidogesic Df Product Label Images

Actidogesic Df 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 Caplet)

Acetaminophen, 500 mgDexbrompheniramine Maleate, 1 mg

Purpose

Pain reliever/Fever reducerAntihistamine

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 8 caplets (4,000 mg) in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this productAllergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash • Caution: May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when driving a motor vehicle or operating machinery. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Do not use • with any other drug containing acetaminophen (prescription or non-prescription) this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns. If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist • if you are allergic to acetaminophen or any of the inactive ingredients in the product • for more than 10 days for pain, unless directed by a doctor.Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, if you have glaucoma or difficulty in urination due to enlargement of the prostate gland.Ask a doctor before use • if you have liver disease • if you are taking the blood thinning drug warfarin.Stop using this product and ask a doctor if• pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present • These could be signs of a serious condition.If pregnant or breast-feeding, ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Adults and children12 years of age and olderTake 2 caplets every 4 to 6 hours as needed,do not exceed 8 caplets in 24 hours, or asdirected by a doctor, do not use for more than10 days unless directed by a doctor.Children under 12  years of age Do not use.

Other Information

• Tamper Evident. Do not use if inner seal is torn, broken, or missing• Store at controlled room temperature 15°- 30°C (59°- 86°F)• Avoid excessive heat or humidity

* Please review the disclaimer below.