NDC 70000-0036 Acetaminophen

Acetaminophen

NDC Product Code 70000-0036

NDC 70000-0036-1

Package Description: 100 TABLET in 1 BOTTLE

NDC Product Information

Acetaminophen with NDC 70000-0036 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Acetaminophen is acetaminophen. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Cardinal Health

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 500 mg/1

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: Cardinal Health
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: 05-28-2019 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: 12-31-2020 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.

Acetaminophen Product Label Images

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

Drug Facts

Active ingredient Acetaminophen 500 mg

Otc - Purpose

PurposePain Reliever/ Fever Reducer

Uses

Temporarily reduces fever and relieves minor aches and pains due to:● headache● muscular aches● common cold● toothache● backache● minor pain of arthritis● premenstrual and menstrual cramps

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
● more than 4,000 mg 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.

Otc - Do Not Use

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.● if you are allergic to acetaminophen or any of the inactive ingredients in this product

Otc - Ask Doctor

Ask a doctor before use if you have liver disease

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Otc - Stop Use

Stop use 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 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.

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● do not take more than 6 tablets in 24 hours, unless directed by a doctor● do not take for more than 10 days unless directed by a doctorchildren under 12 years: ask a doctor

Other Information

Store at room temperature

Inactive Ingredient

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Other

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Extra Strength.DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017www.myleader.com 1-800-200-6313TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING100% Money Back GuaranteeReturn to place of purchase if not satisfied.

* Please review the disclaimer below.

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