NDC 11822-0104 Pain Relief Regular Strength

Acetaminophen

  1. Labeler Index
  2. Rite Aid Corporation
  3. NDC: 11822-0104 Pain Relief Regular Strength

NDC Product Code 11822-0104

NDC CODE: 11822-0104

Proprietary Name: Pain Relief Regular Strength 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 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.
  • This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
44;104
Score: 2

NDC Code Structure

NDC 11822-0104-1

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

NDC 11822-0104-7

Package Description: 1 BOTTLE in 1 CARTON > 125 TABLET in 1 BOTTLE

NDC Product Information

Pain Relief Regular Strength with NDC 11822-0104 is a a human over the counter drug product labeled by Rite Aid Corporation. The generic name of Pain Relief Regular Strength is acetaminophen. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Rite Aid 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.

Pain Relief Regular Strength 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 325 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.
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

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: Rite Aid Corporation
Labeler Code: 11822
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: 07-13-1990 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: 12-31-2021 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]

* Please review the disclaimer below.

Pain Relief Regular Strength Product Label Images

Pain Relief Regular Strength 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

Active Ingredient (In Each Tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily relieves minor aches and pains due to:the common coldheadachebackacheminor pain of arthritistoothachemuscular achespremenstrual and menstrual crampstemporarily reduces fever

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur ifadult takes more than 4,000 mg of acetaminophen in 24 hourschild takes more than 5 doses in 24 hourstaken with other drugs containing acetaminophenadult has 3 or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away.

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.if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask A Doctor Before Use If The User Has

Liver disease.

Ask A Doctor Or Pharmacist Before Use If The User Is

Taking the blood thinning drug warfarin.

Stop Use And Ask A Doctor If

  • Pain gets worse or lasts more than 10 days in adultsredness or swelling is presentpain gets worse or lasts more than 5 days in children under 12 yearsnew symptoms occurfever gets worse or lasts more than 3 daysThese could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

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.

Directions

  • Do not take more than directed children 12 years and over■ take 2 tablets every 4 to 6 hours while symptoms last■ do not take more than 10 tablets in 24 hours■ do not take for more than 10 days unless directed by a doctor children 6-11 years■ take 1 tablet every 4 to 6 hours while symptoms last■ do not take more than 5 tablets in 24 hours■ do not take for more than 5 days unless directed by a doctor children under 6 yearsask a doctorask a doctor

Other Information

  • Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)see end flap for expiration date and lot number

Inactive Ingredients

Corn starch, povidone, sodium starch glycolate, stearic acid

* Please review the disclaimer below.