NDC 81238-3500 Aramark Papenol

Acetaminophen

NDC Product Code 81238-3500

NDC 81238-3500-1

Package Description: 50 PACKET in 1 BOX > 2 CAPSULE in 1 PACKET

NDC 81238-3500-2

Package Description: 125 PACKET in 1 BOX > 2 CAPSULE in 1 PACKET

NDC Product Information

Aramark Papenol with NDC 81238-3500 is a a human over the counter drug product labeled by Western First Aid Safety Dba Aramark. The generic name of Aramark Papenol is acetaminophen. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Western First Aid Safety Dba Aramark

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

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.

Aramark Papenol 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.

  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POVIDONE (UNII: FZ989GH94E)
  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

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: Western First Aid Safety Dba Aramark
Labeler Code: 81238
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: 05-14-2021 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".

* Please review the disclaimer below.

Aramark Papenol 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

Otc - Active Ingredient

Drug FactsActive Ingredient (in each tablet)Acetaminophen 500 mg

Otc - Purpose

PurposeAcetaminophen ...................Pain Reliever/Fever Reducer

Indications & Usage

Uses:Temporarily Relieves minor aches and painsdue to:• Headache, toothaches, menstrual cramps,  the common cold,• muscular aches, minor pain of arthritis  Temporarily reduces fever

Warnings

Warnings:Allergy Alert: Acetaminophen may cause a severe skinreactions.Symptoms may include:• Skin reddening •Blisters •Rash• If a skin reaction occurs, stop use and seek medical  right away.Liver Warning: This product contains anacetaminophen. Severe liver damage may occur if youtake:• more than 8 tablets in 24 hours, which is themaximum daily amount• 3 or more alcoholic drinks every day while using thisproduct• take more or for a longer time than directed

Otc - Do Not Use

Do not use:• if you have ever had an allergic reaction to any  other pain• reliever/fever reducer• right before or after heart surgery• if you have ever had an allergic reaction to this  product or any of its ingredients

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:• under a doctor’s care for any serious condition• taking the blood thinning drug Warfarin

Otc - When Using

When using this product:• take with food or milk if stomach upset occurs• the risk of heart attack or stroke may increase if  you use more than directed or for longer than  directed

Otc - Stop Use

Stop use and ask a doctor if:• pain gets worse lasts more than 10 days• feel faint• pain gets worse or lasts more than 10 days• fever gets worse or lasts more than 3 days• redness or swelling is present in the painful area• any new symptoms occur

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a healthprofessional 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 Centerright away. Prompt medical attention is critical foradults as well as for children even if you do notnotice any signs or symptoms.

Dosage & Administration

Directions:• do not take more than directed• adults and children 12 years and over: take 2  tablets every 4 to 6 hours as needed• do not exceed 8 tablets in 24 hours, unless  directed by a doctor• Children under 12 years: Do not use this product

Other Safety Information

Other information:read all warnings and directions before use. Keepcarton. Store at 20-25°C (68-77°F) avoid excessiveheat above 40°C (104°F)

Inactive Ingredient

Inactive Ingredients:Microcrystalline Cellulose, Povidone, Sodium StarchGlycolate, Starch, Stearic Acid

Package Labeling

Aramark100 TABLETS        Part # 90433BPER BOXExtra StrengthAcetaminophenPain Reliever/Fever ReducerTemporary relief of minor aches andpains associated with a cold,headache, tootache, muscular aches,and for the reduction of feverCompare active ingredient to:Extra Strength Tylenol®Registered Trademark of Johnson & JohnsonMANUFACTURED FOR:AramarkLenexa, KS 66219866-362-2691aramarkuniform.comRetain carton for complete product information100 Tablet Box250 Tablet Box2-Tablet Packetres

* Please review the disclaimer below.