NDC 51824-085 Careall Acetaminophen


NDC Product Code 51824-085

NDC 51824-085-01

Package Description: 100 TABLET in 1 BOTTLE

NDC Product Information

Careall Acetaminophen with NDC 51824-085 is a a human over the counter drug product labeled by New World Imports, Inc. The generic name of Careall Acetaminophen 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 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 325 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.


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. Values = ‘Y’ or ‘N’.

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Careall Acetaminophen Product Label Images

Careall Acetaminophen 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 325mg


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 immediately (1-800-222-1222).  Quick medical attention is critical for adults as well as for chidren even if you do not notice any signs or symptoms.


Temporary relieves minor aches and pains due to:the common cold, headache, toothache, muscular aches, backache, minor pain of arthritis, premenstrual and menstrual cramps, and reduction of fever


Liver warning: This product contains acetaminophen.  Severe liver damage may occur if:Adult takes more than 4,000mg of acetaminphen in 24 hoursChild takes more than 5 doses in 24 hoursTaken with other drugs containing acetaminophenAdult has 3 or more alcoholic drinks every day while using this productAllergy Alert: Acetaminophen may cause severe skin reactions.  Symptoms may include: skin reddening, blisters or rash.  If a 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 allergic to acetaminophen or any of the inactive ingredients in this product.Ask a doctor before use if user has: liver diseaseAsk a doctor or pharmacist before use if:the user is taking the blood thinnig drug warfarin.Stop use and ask a doctor if:Pain gets worse or lasts for more than 10 days. Pain gets worse or lasts more than 5 days in children under 12 years. Fever gets worse or lasts for 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. ​

Dosage & Administration

Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours while symptoms lastDo not take more than 10 tablets in 24 hours.Do not use for more than 10 days unless directed by a doctorChildren 6-11 years of age:Take 1 tablet every 4 to 6 hours while symptoms last.  Do not take more than 5 tablets in 24 hours.Do not use for more than 5 days unless directed by a doctorChildren under 6 years of age: Ask a doctor

Inactive Ingredient

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

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