NDC 51824-086 Careall Acetaminophen Extra Strength

Acetaminophen

  1. Labeler Index
  2. New World Imports, Inc
  3. NDC: 51824-086 Careall Acetaminophen Extra Strength

NDC Product Code 51824-086

NDC CODE: 51824-086

Proprietary Name: Careall Acetaminophen Extra Strength 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: Acetaminophen 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 drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

Product Characteristics

Color(s):
WHITE (C48325 - WHITE)
Shape: ROUND (C48348)
Size(s):
12 MM
Imprint(s):
M2A4;57344
Score: 1

NDC Code Structure

  • 51824 - New World Imports, Inc

NDC 51824-086-01

Package Description: 100 TABLET in 1 BOTTLE

NDC Product Information

Careall Acetaminophen Extra Strength with NDC 51824-086 is a a human over the counter drug product labeled by New World Imports, Inc. The generic name of Careall Acetaminophen Extra Strength is acetaminophen. The product's dosage form is tablet and is administered via oral form.

Labeler Name: New World Imports, 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.

Careall Acetaminophen Extra Strength 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, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • POVIDONE (UNII: FZ989GH94E)
  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

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: New World Imports, Inc
Labeler Code: 51824
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: 03-18-2021 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: 12-31-2022 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.

Careall Acetaminophen Extra Strength Product Label Images

Careall Acetaminophen Extra Strength 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

Acteminophen 500 mg

Purpose

Pain reliever / Fever reducer

Keep Out Of Reach Of Children

Keep out of reach of children.Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).  Quick medical attention is critcal for adults as well as for children even if you do not notice any signs or symptoms.

Uses

Temporary relief of minor aches and pains due to: the common cold, headache, toothache, muscular aches, backache, arthritis, premenstrual and menstrual cramps, and temporarily reduces fever.

Warnings

Liver Warning:This product contains acetaminophen. Severe liver damage may occur if you take:-Adults take more than 4,000mg of Acetaminophen in 24 hours-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.  If a skin reaction occurs, stop use and seek medical help right away.Do not use:-If you are allergic to Acetaminophen or any of the inactive ingredients in this product.-With other products containing acetaminophen (prescription or nonprescription).  If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.Ask a doctor before use if you have liver diseaseAsk a doctor or pharmacist before use if you are taking the blood thinning drug warfarinStop use and ask a doctor if:-Pain gets worse or lasts for more than 10 days-Fever gets worse or lasts for more than 3 days-New symptoms occur-Redness or swelling is presentThese could be signs of a serious condition.If pregnant of breast-feeding, ask a health professional before use.

Dosage & Administration

Do not take more than directed (see overdose warning)  Adults and children 12 years of age and older: Take 2 tablets every 6 hours while symptoms last  Do not take more than 6 tablets in 24 hours, unless directed by a doctorDo not use more than 10 days unless directed by a doctorChildren under 12 years of age: ask a doctor

* Please review the disclaimer below.