NDC 10884-2228 Bf-paradac

Acetaminophen

NDC Product Code 10884-2228

NDC 10884-2228-2

Package Description: 2 BLISTER PACK in 1 CARTON > 10 TABLET in 1 BLISTER PACK

NDC Product Information

Bf-paradac with NDC 10884-2228 is a a human over the counter drug product labeled by Bright Future Pharmaceutical Laboratories Limited. The generic name of Bf-paradac is acetaminophen. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Bright Future Pharmaceutical Laboratories Limited

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.

Bf-paradac 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

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.

  • STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
  • POVIDONE (UNII: FZ989GH94E)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

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: Bright Future Pharmaceutical Laboratories Limited
Labeler Code: 10884
FDA Application Number: part343 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: 09-19-2001 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.

Information for Patients

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]

* Please review the disclaimer below.

Bf-paradac Product Label Images

Bf-paradac 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 Ingredient

Acetaminophen 500 mg

Purpose

Pain Relievers - Fever Reducer

Uses

For the temporary relief of minor aches and pains associated with the common cold, headache, toothache, muscular aches, to reduce fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:• More than 6tablets 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 cayse severe skin reactions. Symptoms may include• Skin reddening• Blisters• RashIf skin reaction occurs, stop use and seek medical help right away

Do Not Use

• With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.• For more than 10 days for pain unless directed by a doctor• For more than 3 days for fever unless directed by a doctor

Ask Doctor Before Use If You Have

Liver disease

Ask Doctor Or Pharmacist Before Use If

You are taking the blood thinning drug warfarin

Stop Using And Ask A Doctor If

• Symptoms do not improve• New symptoms occur• Pain or fever persists or gets worse

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

Do not take more than directed (see overdose warning)Adults and children 12 years and over:• Take 2 tablets every 6 hours while symptoms last• Swallow whole – do not crush, chew or dissolve• Do not take more than 6 tablets in 24 hours, unless directed by a doctor• Do not use for more than 10 days unless directed by a doctorChildren under 12 years• Ask a doctor

Other Information

* Don’t store above 25°C     * keep tightly closed.

Inactive Ingredients

Corn starch, Ethylparaben, Povidone, Propylparaben, Stearic acid, Pregelatinized starch, sodium starch glycollate

* Please review the disclaimer below.