NDC 81238-0140 Aramark Fedrin

Acetaminophen, Phenylephrine Hcl

NDC Product Code 81238-0140

NDC 81238-0140-1

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

NDC 81238-0140-2

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

NDC Product Information

Aramark Fedrin with NDC 81238-0140 is a a human over the counter drug product labeled by Western First Aid Safety Dba Aramark. The generic name of Aramark Fedrin is acetaminophen, phenylephrine hcl. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Western First Aid Safety Dba Aramark

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.

Aramark Fedrin 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
  • PHENYLEPHRINE HYDROCHLORIDE 5 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.

  • STARCH, CORN (UNII: O8232NY3SJ)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POVIDONE (UNII: FZ989GH94E)
  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • WATER (UNII: 059QF0KO0R)

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: part341 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 05-07-2021 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 Fedrin 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 mgPhenylephrine HLC 5 mg

Otc - Purpose

PurposeAcetaminophen ...................Pain reliever/fever reducerPhenylephrine HCl ................Nasal decongestant

Indications & Usage

Uses:Temporarily relieves these symptomsassociated with hay fever or otherrespiratory allergies and the common cold:• headache                   • sinus congestion and pressure• nasal congestion       • minor aches and pains                                    • promotes sinus drainage                                    • temporarily reduces fever

Warnings

Warnings:Liver warning: This product contains acetaminophen.The maximum daily dose of this product is 6 tablets(3,000 mg acetaminophen) in 24 hours. Severe liverdamage 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 thisproductAllergy alert: acetaminophen may cause serve skinreactions. Symptoms may include:•skin reddening •blister •rashIf a skin reaction occurs, stop use and seek medicalhelp right away

Otc - Do Not Use

Do not use•with any other drug containing acetaminophen. Ifyou are not sure whether a drug containsacetaminophen, ask a doctor or pharmacist.•if you are now taking a prescription monoamineoxidase inhibitor (MAOIs), or for 2 weeks afterstopping the MAOI drug. If you do not know ifyour prescription drug contains an MAOI, ask adoctor or pharmacist before taking this product.•if you have ever had an allergic reaction to thisproduct or any of its ingredients.

Otc - Ask Doctor

Ask a doctor before use if you have:• liver disease• diabetes• heart disease• high blood pressure• thyroid disease• trouble urinating due to an enlarged prostate  gland

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug Warfarin

Otc - When Using

When using this product do not exceedrecommended dose

Otc - Stop Use

Stop use and ask a doctor if:• nervousness, dizziness, or sleeplessness occur• pain or nasal congestion gets worse or lastsmore than 7 days• fever gets worse or lasts more than 3 days• redness or swelling is present• new symptoms occurThese could be signs of a serious condition.

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 childrenOverdose warning: in case of overdose, getmedical help or contact a Poison Control Centerright away. (1-800-222-1222) Quick medicalattention is critical for adults as well as for childreneven if you do not notice any signs or symptoms.

Dosage & Administration

Directions:• do not take more than directed (see  overdose warning)• adults and children 12 years and over:  • take 2 tablet every 4 hours  • swallow whole; do not crush, chew or  dissolve  • do not take more than 6 tablets in 24     hours• children under 12 years: ask a doctor

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:Corn Starch, FD & C Blue #1 Lake, MicrocystallineCellulose, Povidone, Sodium Starch Glycolate,Stearic Acid, USP Purified Water

Package Labeling

Aramark100 TABLETS         Part # 91933BPER BOXFEDRINPain Reliever/Nasal DecongestantTemporary relief of headaches,sinus pain, nasal and sinus congestion,minor aches, pains, feverMANUFACTURED FOR:AramarkLenexa, KS 66219(913) 269-9611aramarkuniform.comRetain carton for complete product information100 Tablet Box250 Tablet Box2-Tablet Packetres

* Please review the disclaimer below.