NDC 68788-7743 Extra Strength Acetaminophen

Acetaminophen Tablet Oral

NDC Product Code 68788-7743

NDC 68788-7743-1

Package Description: 100 TABLET in 1 BOTTLE

NDC 68788-7743-2

Package Description: 20 TABLET in 1 BOTTLE

NDC 68788-7743-3

Package Description: 30 TABLET in 1 BOTTLE

NDC 68788-7743-4

Package Description: 45 TABLET in 1 BOTTLE

NDC 68788-7743-5

Package Description: 50 TABLET in 1 BOTTLE

NDC 68788-7743-6

Package Description: 60 TABLET in 1 BOTTLE

NDC Product Information

Extra Strength Acetaminophen with NDC 68788-7743 is a human over the counter drug product labeled by Preferred Pharmaceuticals, Inc.. The generic name of Extra Strength Acetaminophen is acetaminophen. The product's dosage form is tablet and is administered via oral form.

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.

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.

RxNorm Crosswalk

What is RxNorm?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) (RxCUI) to each NDC.

The RxNorm Crosswalk for this NDC code indicates a single concept unique identifier (RXCUI) is associated with this product:

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: Preferred Pharmaceuticals, Inc.
Labeler Code: 68788
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: 07-01-2020 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.

Extra Strength Acetaminophen Product Label Images

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

Active Ingredients

Acetaminophen 500 mg


Pain Reliever/Fever Reducer


  • •temporarily relieves minor aches and pains •temporarily reduces fever


  • Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets in 24 hours. Severe liver damage may occur if you take: •more than 8 tablets (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 •rashIf 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.Ask a doctor before use if you haveliver disease.Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.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 symptom occur •redness or swelling is presentThese could be signs of a serious condition.If pregnant or breast-feeding, ask a health professional before use..

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


  • •do not take more than directed •adults and children 12 years and over: take 1-2 tablets every 4-6 hours, as needed. Do not take more than 6 tablets in 24 hours, unless directed by a doctor. •children under 12 years: do not use

Other Information

  • •TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken. •store at 20⁰C-25⁰C (68⁰F-77⁰F) Bottle of 20NDC 68788-7743-02Bottle of 30NDC 68788-7743-03Bottle of 45NDC 68788-7743-04Bottle of 50NDC 68788-7743-05Bottle of 60NDC 68788-7743-06Bottle of 100NDC 68788-7743-01

Inactive Ingredients

Povidone, sodium starch glycolate, starch, stearic acid.

* Please review the disclaimer below.