NDC 70000-0509 Leader Extra Strength Acetaminophen

Acetaminophen

NDC Product Code 70000-0509

NDC Code: 70000-0509

Proprietary Name: Leader Extra Strength Acetaminophen 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.

Product Characteristics

Color(s):
RED (C48326 - TRANSPARENT)
Shape: OVAL (C48345)
Size(s):
23 MM
Imprint(s):
710
Score: 1
Flavor(s):
GRAPE (C73391)

NDC Code Structure

  • 70000 - Leader�
    • 70000-0509 - Leader Extra Strength Acetaminophen

NDC 70000-0509-1

Package Description: 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

NDC Product Information

Leader Extra Strength Acetaminophen with NDC 70000-0509 is a a human over the counter drug product labeled by Leader�. The generic name of Leader Extra Strength Acetaminophen is acetaminophen. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: Leader�

Dosage Form: Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.

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.

Leader Extra Strength 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

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.

  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • POVIDONE K30 (UNII: U725QWY32X)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WATER (UNII: 059QF0KO0R)
  • SORBITAN (UNII: 6O92ICV9RU)
  • SORBITOL (UNII: 506T60A25R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: Leader�
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: 07-10-2019 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.

Leader Extra Strength Acetaminophen Product Label Images

Leader Extra Strength 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

Active Ingredient (In Each Softgel)

Acetaminophen 500 mg

Purpose

Pain reliever/ fever reducer

Uses

■ temporarily relieves minor aches and pains due to:





■ the common cold ■ headache ■ backache





■ minor pain of arthritis ■ toothache ■ muscular aches





■ premenstrual and menstrual cramps





■ temporarily reduces fever

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 product





Allergy 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

■ 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

■ 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 present





These 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.

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 softgels every 6 hours while





symptoms last





■ do not take more than 6 softgels in





24 hours unless directed by a doctor





■ do not use for more than 10 days





unless directed by a doctor





 children under





12 years





 ask a doctor

Other Information







each softgel contains: sodium 7 mg





■ store between 15°-30°C (59°-86°F)

Inactive Ingredients

FD&C Red #40, gelatin, glycerin, polyethylene glycol 400,





potassium hydroxide, povidone, propylene glycol, purified





water, sodium hydroxide, sorbitol, sorbitol sorbitan solution





titanium dioxide

Otc - Questions

Questions or Comments? 1-888-333-9792

* Please review the disclaimer below.

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