NDC 42961-111 First Aid Direct Backache And Muscle Relief

Acetaminophen Magnesium Salicylate

NDC Product Code 42961-111

NDC CODE: 42961-111

Proprietary Name: First Aid Direct Backache And Muscle Relief 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: Acetaminophen Magnesium Salicylate 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.

NDC Code Structure

  • 42961 - Cintas Corporation
    • 42961-111 - First Aid Direct Backache And Muscle Relief

NDC 42961-111-83

Package Description: 80 PACKET in 1 BOX > 2 TABLET in 1 PACKET (42961-111-81)

NDC Product Information

First Aid Direct Backache And Muscle Relief with NDC 42961-111 is a a human over the counter drug product labeled by Cintas Corporation. The generic name of First Aid Direct Backache And Muscle Relief is acetaminophen magnesium salicylate. 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.

First Aid Direct Backache And Muscle 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.

  • ACETAMINOPHEN 250 mg/1
  • MAGNESIUM SALICYLATE 290 mg/1
  • CAFFEINE 50 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.

  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POVIDONE (UNII: FZ989GH94E)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • 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: 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: 03-25-2021 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.

First Aid Direct Backache And Muscle Relief Product Label Images

First Aid Direct Backache And Muscle 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

Purpose(S)

Active ingredients (in each tablet)Acetaminophen 250 mg.........pain reliever/fever reducerMagnesium salicylate 290mg (NSAID*)..pain reliever/fever reducerCaffeine 50mg......................adjuvant/alertness aid*Nonsteroidal anti-inflammatory drug

Active Ingredients

Active ingredients (in each tablet)• Acetaminophen 250mg…………………………………….pain reliever/fever reducer• Magnesium Salicylate 290mg (NSAID*)………………….pain reliever/fever reducer• Caffeine 50mg……………………………………………..adjuvant/alertness aid

Inactive Ingredients

Hypromellose, maltodextrin, microcrystalline cellulose, povidone, polyethylene glycol, starch 1551, stearic acid, titanium dioxide

Uses

  • Temporarily relieves minor aches and pains associated with:Muscular achesBackache

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.Allergy alert: Allergy alert: Magnesium Salicylate may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms mayinclude: ■ hives ■ asthma (wheezing) ■ facial swelling ■ shock ■ skin reddening ■ rash ■ blistersLiver 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 product.Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash If a skin reaction occurs, stop use and seek medical help right away.Stomach bleeding warning: This product contains an NSAID, 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 or nonprescription 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 directedCaffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.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. ■ if you are allergic to aspirin or salicylates ■ for more than 10 days for pain unless directed by a doctor ■ for more than 3 days for fever unless directed by a doctor ■ for children under 3 years of age unless directed by a doctorAsk a doctor before use if ■ stomach bleeding warning applies to you■ you have liver disease, high blood pressure, heart disease, liver cirrhosis, asthma or kidney disease ■ you are taking a diuretic ■ you have a history of stomach problems, such as heartburnAsk a doctor or pharmacist before use if you are taking a prescription drug for ■ anticoagulation (thinning of the blood) ■ diabetes ■ gout ■ arthritisWhen using this product do not exceed recommended dose.Stop use and ask 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■ symptoms do not improve ■ pain or fever persists or gets worse ■ new symptoms occur ■ redness or swelling is present ■ ringing in the ears or loss of hearing occursIf pregnant or breast-feeding, ask a health professional before use.Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.Prompt medical attention is required for adults as well as children even if you do not notice any signs or symptoms.

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 Center right away.Prompt medical attention is required for adults as well as children even if you do not notice any signs or symptoms.

Directions

Adults and children 12 years and older: Take 1 to 2 tablets every 6 hours while symptoms persist, not to exceed 8 tablets in 24 hours, or as directed by a doctor.Children under 12 years of age: Ask a doctor

Other Information

■ do not use if packet is torn, cut or opened ■ store at room temperature ■ avoid excessive heat and humidityQuestions? 1-800-327-270480 Tablets/2 Tablets per Packet

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