NDC 41520-336 Acetaminophen-apap 8 Hour

Product Information

Product Code41520-336
Proprietary Name 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.
Acetaminophen-apap 8 Hour
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
American Sales Company
Labeler Code41520
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
04-30-2002
Listing Expiration Date 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.
12-31-2019
Exclude Flag 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".
I
NDC Code Structure

Usage Information


Product Characteristics

Color(s)WHITE (C48325)
ShapeOVAL (C48345)
Size(s)9 MM
Imprint(s)COR116
Score1

Product Packages

NDC 41520-336-23

Package Description: 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Acetaminophen-apap 8 Hour is product labeled by American Sales Company. The product's dosage form is and is administered via form.


What are Acetaminophen-apap 8 Hour Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

  • ACETAMINOPHEN (UNII: 362O9ITL9D)
  • ACETAMINOPHEN (UNII: 362O9ITL9D) (Active Moiety)


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


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.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POVIDONE (UNII: FZ989GH94E)
  • STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)


* Please review the disclaimer below.

Patient Education

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.

Acetaminophen-apap 8 Hour Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredient (In Each Caplet)



Acetaminophen USP, 650 mg


Purpose



Pain reliever/fever reducer


Uses



  • temporarily relieves minor aches and pains due to:
    • muscular aches
    • headache
    • minor pain of arthritis
    • backache
      • temporarily reduces fever

Warnings



Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 6 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

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 You Have



Liver disease.


Ask A Doctor Or Pharmacist Before Use If You Are



Taking the blood thinning drug warfarin.


Stop Use And Ask A Doctor If



  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • These could be signs of a serious condition.


If Pregnant Or Breast-Feeding



Ask a health professional before use.


Keep Out Of Reach Of Children.



Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick 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 (see overdose warning)
    adults and children 12 years and over ▪ take 2 caplets every 8 hours with water
    ▪ swallow whole - do not crush, chew, split or dissolve
    ▪ do not take more than 6 caplets in 24 hours
    ▪ do not use for more than 10 days unless directed by a doctor
    children under 12 years ▪ do not use

Other Information



  • store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).
  • see end panel for batch number and expiration date
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

Inactive Ingredients



Croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide


Questions?



Call 1-888-423-0139


Principal Display Panel



Compare to the Active Ingredient in Tylenol®8 Hour**

CAREONE®

Use only as directed.

Lasts up to 8 HOUR

PAIN RELIEF

Acetaminophen Extended-Release Tablets, USP 650 mg

PAIN RELIEVER · FEVER REDUCER

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

For Up To 8 Hour Relief of Minor Muscle Aches & Pain

24 CAPLETS*650 mg Each

*Capsule-Shaped Tablets

DISTRIBUTED BY: AMERICAN SALES COMPANY

5089223/R0811


* Please review the disclaimer below.