NDC 42961-399 Xpect Acetaminophen


NDC Product Information

Xpect Acetaminophen with NDC 42961-399 is a a human over the counter drug product labeled by Cintas Corporation. The generic name of Xpect Acetaminophen is acetaminophen. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Cintas Corporation

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.

Xpect 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.


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: Cintas Corporation
Labeler Code: 42961
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: 03-30-2021 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 ("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".

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Xpect 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


Pain reliever/Fever reducer

Keep Out Of Reach Of Children

Keep out of reach of children.Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Active Ingredients

Active ingredient (in each tablet)• Acetaminophen 500mg……………….Pain reliever/Fever reducer

Inactive Ingredients

Corn starch, hydroxypropyl methylcellulose, polyethylene glycol, pregelatinized starch, stearic acid, titanium dioxide. May contain povidone and sodium starch glycolate.


Temporarily relieves fever and minor aches and pains associated with:• Headache• Common cold• Muscular aches• Backache• Menstrual cramps• Toothache• Minor arthritis pain


Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:• More than 8 tablets in 24 hours, which is the maximum daily amount.• 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 skin reaction occurs, stop use and seek medical help right away.Do not use• With any other product 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 have liver disease.Ask a doctor or pharmacist before use if are taking 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 symptoms occur• Redness or swelling is presentThese could be signs of a serious condition.If pregnant or breast-feeding, ask a health professional before use.Keep out of reach of children.Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt attention is critical for adults as well as children even if you do not notice any signs or symptoms.


Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor.Children under 12 years of age: Do not use this product; this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concern.

Other Information

• Do not use if packet is torn, cut, or opened• Store at room temperature• Avoid excessive heat and humidity• Single Dose• Tamper Evident• Non-Drowsy• Aspirin-freeSee new warnings informationQuestions? 1-877-973-2811 Monday – Friday 8AM – 5PM250 Tablets/2 Tablets per PacketProduct #111399

* Please review the disclaimer below.