NDC 70000-0152 Acetaminophen

Acetaminophen

NDC Product Code 70000-0152

NDC 70000-0152-2

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 100 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Acetaminophen with NDC 70000-0152 is a a human over the counter drug product labeled by Cardinal Health, Inc.. The generic name of Acetaminophen is acetaminophen. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Cardinal Health, 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.

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.

  • STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
  • POVIDONE (UNII: FZ989GH94E)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • 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: Cardinal Health, Inc.
Labeler Code: 70000
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: 11-28-2016 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 05-31-2021 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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.

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

Other

Drug Facts

DISTRIBUTED BYCARDINAL HEALTHDUBLIN, OHIO 43017www.myleader.com1-800-200-6313

Otc - Active Ingredient

Active ingredient (in each tablet)Acetaminophen 325 mg

Otc - Purpose

PurposesPain reliever/fever reducer

Indications & Usage

  • Usestemporarily relieves minor aches and pains due to:headachemuscular achesbackacheminor pain of arthritistoothachethe common coldpremenstrual and menstrual crampstemporarily reduces fever

Warnings

  • WarningsLiver warning: This product contains acetaminophen. Severe liver damage may occur if
  • Adult takes more than 4,000 mg of acetaminophen in 24 hourschild takes more than 5 doses in 24 hours, which is the maximum daily amounttaken with other drugs containing acetaminophenadult has 3 or more alcoholic drinks every day while using this product.Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
  • Skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away.

Otc - Do Not Use

  • Do not usewith any other drug containing acetaminophen (prescription or nonprescription). 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 this product

Otc - Ask Doctor

Ask a doctor before use if the user has liver disease.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.

Otc - Stop Use

  • Stop use and ask a doctor ifpain gets worse or lasts more than 10 days in adultspain gets worse or lasts more than 5 days in children under 12 yearsfever gets worse or lasts more than 3 daysnew symptoms occurredness or swelling is presentThese could be signs of a serious condition.

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.

Overdosage

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 critical for adults as well as for children even if you do not notice any signs or symptoms.

Dosage & Administration

  • Directionsdo not take more than directed (see overdose warning)adults and children 12 years and overtake 2 tablets every 4 to 6 hours while symptoms lastdo not take more than 10 tablets in 24 hours unless directed by a doctordo not use for more than 10 days unless directed by a doctorchildren 6 years to under 12 yearstakes 1 tablet every 4 to 6 hours while symptoms lastdo not take more than 5 tablets in 24 hoursdo not use for more than 5 days unless directed by a doctorchildren under 6 yearsask a doctor

Storage And Handling

  • Other informationstore at room temperature

Inactive Ingredient

Inactive ingredients Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Otc - Questions

Questions or Comments?call
(800) 795-9775

Other Safety Information

Do not use if carton is open, or if imprinted safety seal under cap is broken or missing

* Please review the disclaimer below.