NDC 81238-1118 Aramark Back Relief

Magnesium Salicylate

NDC Product Code 81238-1118

NDC 81238-1118-1

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

NDC Product Information

Aramark Back Relief with NDC 81238-1118 is a a human over the counter drug product labeled by Western First Aid Safety Dba Aramark. The generic name of Aramark Back Relief is magnesium salicylate. The product's dosage form is tablet and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 283274.

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 Back Relief 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.


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.

  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: 06-14-2021 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 Back Relief 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

Active Ingredient (in each tablet)Acetaminophen 250 mgCafeine 50mg*Nonsteroidal anti-inflammatory drugMagnesium Salicylate (NSAID) 290 mg

Otc - Purpose

PurposeAcetaminophen ....Pain Reliever/Fever ReducerCafeine .........................................Adjuvent*Nonsteroidal anti-inflammatory drugMagnesium Salicylate (NSAID) ......Pain Reliever

Indications & Usage

Uses:Temporarily Relieves minor aches and painsassociated with: • back pain • muscular aches

Warnings

Warnings:Reye’s Syndrome: Children and teenagers should not   use this medicine for chicken pox or flu symptoms   before a doctor is consulted about Reye’s Syndrome,   a rare but serious illness reported to be associated   with aspirin.Allergy Alert: Saticylates (NSAIDs) may cause a severe   allergic reaction which may include: • hives • shock   • facial swelling • asthma (wheezing)If a skin or allergic reaction occurs, stop useand seek medical help right away.Liver Warning: This product contains acetaminophen.   Severe liver damage may occur if you take:   • more than 8 tablets in 24 hours   • with other drugs containing acetaminophen  (prescription or nonprescription)   • Ask a doctor or pharmacist before using with  other drugs if you are not sure.   • 3 or more alcoholic drinks every day while using   this product.Stomach Bleeding Warning: This product contains   nonsteroidal anti-inflammatory drugs (NSAIDs),   which may cause 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 an NSAID (aspirin,     ibuprofen, naproxen, or others)   • take more or for a longer time than directed• Do not use:   • with any other pain reliever/fever reducer   • for pain for more than 10 days or for fever for     more than 3 days unless directed by a doctor   • with any other product containing     acetaminophen   • right before or after heart surgeryAsk a doctor before using if you have:• upset stomach or stomach pain • ulcers• bleeding problems • high blood pressure • heart or  kidney disease • taken a diuretic • reached age 60  or olderAsk a doctor or pharmacist before use if you are:• taking any other drug containing an NSAID(prescription or nonprescription)• taking a blood thinning (anticoagulant) orsteroid drugWhen using this product do not exceed therecommended dose.Caffeine warning: The recommended dose of thisproduct contains about as much caffeine as a cup of coffee.Limit the use of careline-containing medications, foods, orbeverages while taking this product because too much carelinemay cause nervousness, irritability, sleeplessness, and,occasionally, rapid heartbeat.Stop use and ask a doctor if:• ringing in the ears or loss of hearing occurs• pain or fever persists or gets worse• new symptoms occur• redness or swelling is present• you feel faint, vomit blood, or have bloody or  black stools.• These are signs of stomach bleeding.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding baby, ask a healthprofessional before use. IT IS ESPECIALLYIMPORTANT NOT TO USE ASPIRIN DURING THELAST 3 MONTHS OF PREGNANCY UNLESSSPECIFICALLY DIRECTED TO DO SO BY A DOCTORBECAUSE IT MAY CAUSE PROBLEMS IN THEUNBORN CHILD OR COMPLICATIONS DURINGDELIVERY.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.In case of overdose, get medical help or contact aPoison Control Center right away. Prompt medicalattention is critical for adults as well as childreneven if you do not notice any signs or symptoms.

Dosage & Administration

Directions:• Adults andchildren 12 yearsof age and older:2 tablets asneeded for painevery 4 hours. Donot exceed 8 tabletsin 24 hours or asdirected by a doctor.• Children under12 years:Do not give tochildren under 12 yearsof age

Other Safety Information

Other Information:• read all product information before using• store at room temperature 59°-86°F (15°-30°C)• avoid excessive heat and humidity• tamper-evident sealed packets• do not use any opened or torn packets

Inactive Ingredient

Inactive Ingredients:hypromellose, maltodextrin, microcrystallinecellulose, polyethylene glycol, povidone,starch 1551, stearic acid, titanium dioxide

Product Labeling

Aramark100 Tablets                        Part # 07333Per BoxBack ReliefPain Reliever/Fever ReducerMANUFACTURED FOR:AramarkLenexa, KS 66219(866) 362-2691aramarkuniform.comRetain carton for complete product information100 Tablet Box2-tablet Packet

* Please review the disclaimer below.