NDC 81238-0103 Aramark Ibuprofen

Ibuprofen

NDC Product Code 81238-0103

NDC CODE: 81238-0103

Proprietary Name: Aramark Ibuprofen 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: Ibuprofen 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Ibuprofen is used to help relieve mild to moderate pain. When used with an opioid (such as morphine), it may be used to relieve moderate to severe pain. It is also used to reduce fever. Ibuprofen is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.

NDC Code Structure

NDC 81238-0103-1

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

NDC 81238-0103-2

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

NDC Product Information

Aramark Ibuprofen with NDC 81238-0103 is a a human over the counter drug product labeled by Western First Aid Safety Dba Aramark. The generic name of Aramark Ibuprofen is ibuprofen. 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 Ibuprofen 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.

  • IBUPROFEN 200 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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • POVIDONE (UNII: FZ989GH94E)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIACETIN (UNII: XHX3C3X673)
  • 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: 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".

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Aramark Ibuprofen 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)​Ibuprofen 200 mg (NSAID)*

Otc - Purpose

PurposeIbuprofen 200 mg (NSAID)*.............Pain Reliever Fever Reducer *nonsteroidal anti-inflammatory drug

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: Ibuprofen may cause a severe allergicreaction, especially in people allergic to aspirin.Symptoms may include:• hives, facial swelling, asthma (wheezing), shock,  skin reddening, rash, blistersStomach bleeding warning: This product contains anNSAID, which may cause severe stomach bleeding.The chance is higher if you:• are age 60 or older• have had stomach ulcers or bleeding problems• take a blood thinning (anticoagulant) or steroid  drug• take other drugs containing prescription NSAIDs  (aspirin, ibuprofen, naproxen, or others)• have 3 or more alcoholic drinks every day while  using this product• 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:• stomach bleeding warning applies to you• you have problems or serious side effects from  taking pain• relievers or fever reducers• you have a history of stomach problems, such  as heartburn• you have high blood pressure, heart disease, liver  cirrhosis, kidney disease, or asthma• you are taking a diuretic

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are:• under a doctor’s care for any serious condition• taking aspirin for heart attack or stroke, because  ibuprofen may decrease the benefit of aspirin• 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:• you experience any of the following signs of   stomach bleeding:• feel faint• vomit blood• have bloody or black stools• have stomach pain that does not get better• 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. It is especially importantnot to use ibuprofen during the last 3 months ofpregnancy unless definitely directed to do so by adoctor because it may cause problems in theunborn child or complications during delivery.

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.

Dosage & Administration

Directions:• do not take more than directed• the smallest effective dose should be used• adults and children 12 years and over: take 1 tablet  every 4 to 6 hours while symptoms persist• if pain or fever does not respond to 1 tablet,  2 tablets may be used• do not exceed 6 tablets in 24 hours, unless  directed by a doctor• 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:colloidal silicon dioxide, corn starch, sodium starchglycollate, hypromellose, lactose monohydrate,povidone, pregelatinized corn starch, red iron oxide,sodium starch glycolate, steric acid, talc, titaniumdioxide, triacetin, purified water

Product Package

Aramark100 TABLETS PER BOX            Part # 552R23IbuprofenAnti-Inflammatory FeverReducerCompare active ingredient to:ADVIL®Registered Trademark of Pfizer Consumer HealthcareRetain carton for complete product informationMANUFACTURED FOR:AramarkLenexa, KS 66219(913) 269-9611aramarkuniform.com100 Tablet Box250 Tablet Box2-Tablet Packetres

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