NDC 42961-047 Pain Aid Esf

Acetaminophen, Aspirin, Caffeine

NDC Product Code 42961-047

NDC CODE: 42961-047

Proprietary Name: Pain Aid Esf 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, Aspirin, Caffeine 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.

Product Characteristics

Color(s):
WHITE (C48325 - SNOW WHITE)
Shape: ROUND (C48348)
Size(s):
12 MM
Imprint(s):
ZEE;ESF
Score: 1

NDC Code Structure

  • 42961 - Cintas Corporation

NDC 42961-047-04

Package Description: 50 CARTON in 1 CARTON > 125 CARTON in 1 CARTON (42961-047-03) > 12 PACKET in 1 CARTON (42961-047-02) > 2 TABLET in 1 PACKET (42961-047-01)

NDC Product Information

Pain Aid Esf with NDC 42961-047 is a a human over the counter drug product labeled by Cintas Corporation. The generic name of Pain Aid Esf is acetaminophen, aspirin, caffeine. The product's dosage form is tablet and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1359083 and 308297.

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.

Pain Aid Esf 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.

  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
  • POVIDONE K29/32 (UNII: 390RMW2PEQ)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • 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.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Anti-Inflammatory Agents -
  • Non-Steroidal - [CS]
  • Central Nervous System Stimulant - [EPC] (Established Pharmacologic Class)
  • Central Nervous System Stimulation - [PE] (Physiologic Effect)
  • Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
  • Decreased Platelet Aggregation - [PE] (Physiologic Effect)
  • Decreased Prostaglandin Production - [PE] (Physiologic Effect)
  • Methylxanthine - [EPC] (Established Pharmacologic Class)
  • Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
  • Platelet Aggregation Inhibitor - [EPC] (Established Pharmacologic Class)
  • Xanthines - [CS]

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: 01-06-2021 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.

Pain Aid Esf Product Label Images

Pain Aid Esf 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 mg, Aspirin 250 mg, Caffeine 65 mg

Otc - Purpose

Purpose-Pain reliever, Fever Reducer

Indications & Usage

Uses■ temporarily relieves pain due to:■ headache ■ muscular aches ■ colds ■ flu■ temporarily reduces fever

Dosage & Administration

  • Directionsadults: take 2 tablets every 6 hours, not more than 8 tablets in24 hourschildren under 12 years: ask a doctor

Warnings

WarningsReye's syndrome: Children and teenagers who have or arerecovering from chicken pox or flu-like symptoms should not usethis product. When using this product, if changes in behavior withnausea and vomiting occur, consult a doctor because thesesymptoms could be an early sign of Reye's syndrome, a rare butserious illness.Allergy alert: Aspirin may cause a severe allergic reaction whichmay include:■ hives ■ facial swelling ■ asthma (wheezing) ■ shockLiver warning: This product contains acetaminophen. Severeliver damage may occur if you take ■ more than 8 tablets in 24hours, which is the maximum daily amount■ with other drugs containing acetaminophen■ 3 or more alcoholic drinks every day while using this productStomach bleeding warning: This product contains anonsteroidal anti-inflammatory drug (NSAID), which may causesevere 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 nonprescriptionNSAIDs (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 productcontains about as much caffeine as a cup of coffee. Limit the use ofcaffeine-containing medications, foods, or beverages while takingthis product because too much caffeine may cause nervousness,irritability, sleeplessness, and, occasionally, rapid heart beat.Do not use■ if you have ever had an allergic reaction to any other painreliever/fever reducer■ with any other drug containing acetaminophen (prescriptionor nonprescription). If you are not sure whether a drugcontains acetaminophen, ask a doctor or pharmacist.Stop use and ask a doctor if■ an allergic reaction occurs. Seek medical help right away.■ 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■ ringing in the ears or loss of hearing occurs■ 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 appearAsk a doctor before use if you are taking a prescription drug for diabetes, gout, or arthritis■ stomach bleeding warning applies to you■ you have a history of stomach problems, such as heartburn you have asthma, high blood pressure, heart disease, live rdisease, or kidney disease■ you are taking a diuretic

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding baby, ask a health professional  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 Center right away.  Prompt medical attention is critical for adults as well as for  children even if you do not notice any signs or symptoms.

Inactive Ingredient

Inactive ingredients cellulose*, hydroxypropylmethylcellulose, maltodextrin*, polyethylene glycol, povidone,propylene glycol*, sodium lauryl sulfate*, sodium starchglycolate, starch, stearic acid, titanium dioxide*contains one or more of these ingredients

* Please review the disclaimer below.