NDC 41226-370 Headache Relief

Acetaminophen, Aspirin And Caffeine

NDC Product Code 41226-370

NDC CODE: 41226-370

Proprietary Name: Headache 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, Aspirin And 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

WHITE (C48325)
Shape: CAPSULE (C48336)
18 MM
Score: 1

NDC Code Structure

NDC 41226-370-01

Package Description: 1 BOTTLE in 1 CARTON > 100 TABLET, COATED in 1 BOTTLE

NDC 41226-370-42

Package Description: 1 BOTTLE in 1 CARTON > 24 TABLET, COATED in 1 BOTTLE

NDC Product Information

Headache Relief with NDC 41226-370 is a a human over the counter drug product labeled by Kroger Company. The generic name of Headache Relief is acetaminophen, aspirin and caffeine. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Kroger Company

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

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.

Headache 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.

  • CAFFEINE 65 mg/1
  • ASPIRIN 250 mg/1
  • ACETAMINOPHEN 250 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.


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: Kroger Company
Labeler Code: 41226
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: 04-10-2021 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.

Headache 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

Drug Facts


Otc - Active Ingredient

Active ingredient (in each caplet)
Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Otc - Purpose

Pain reliever/Pain reliever aid

Indications & Usage

temporarily relieves minor aches and pains due to:


•a cold


•muscular aches


•premenstrual and menstrual cramps


WarningsReye’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: Aspirin may cause a severe allergic reaction, which may include:


•facial swelling


•asthma (wheezing)
Allergyalert: Acetaminophen may cause severe skin reactions. Symptoms may include:

•skin reddening



If a skin reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

•more than 8 caplets 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
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 directed
Caffeine 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.

Otc - Do Not Use

Do not use
•with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

•for more than 10 days for pain unless directed by a doctor

•for more than 3 days for fever unless directed by a doctor

Otc - Ask Doctor

Ask a doctor before use if
•stomach bleeding warning applies to you

•you have a history of stomach problems, such as heartburn

•you have high blood pressure, heart disease, liver cirrhosis or kidney disease

•you are taking a diuretic

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are
•taking a prescription drug for diabetes, gout, or arthritis

•taking any other drug or are under a doctor’s care for any serious condition

Otc - Stop Use

Stop using and ask a doctor if
•symptoms do not improve

•new symptoms occur

•pain or fever persists or gets worse

•you experience any of the following signs of stomach bleeding:

feel faint

have bloody or black stools

vomit blood

have stomach pain that does not get better

•ringing in the ears or loss of hearing occurs, consult a doctor before taking any more of this product.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Dosage & Administration

Directions:•do not use more than directed
•drink a full glass of water with each dose

•adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours

•children under 12 years: ask a doctor

Other Information

  • Other informationstore at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)use by expiration date on package

Inactive Ingredient

Inactive ingredients
carnauba wax, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, mineral oil, pregelatinized starch, povidone, sodium starch glycolate, stearic acid, titanium dioxide

Otc - Questions

Questions or comments?call 1-800-632-6900

* Please review the disclaimer below.