NDC 59779-336 Acetaminophen 8 Hour

NDC Product Code 59779-336

NDC CODE: 59779-336

Proprietary Name: Acetaminophen 8 Hour 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.

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: OVAL (C48345)
Size(s):
19 MM
Imprint(s):
COR116
Score: 1

NDC Code Structure

  • 59779 - Cvs Pharmacy

NDC 59779-336-01

Package Description: 100 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.

NDC Product Information

Acetaminophen 8 Hour with NDC 59779-336 is a product labeled by Cvs Pharmacy. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1148399.

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.

  • 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)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cvs Pharmacy
Labeler Code: 59779
Start Marketing Date: 04-30-2002 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: 12-31-2019 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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".

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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]

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Acetaminophen 8 Hour Product Label Images

Acetaminophen 8 Hour 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 Caplet)

Acetaminophen USP, 650 mg

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily relieves minor aches and pains due to:muscular achesbackacheheadacheminor pain of arthritistemporarily reduces fever

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you takemore than 6 caplets in 24 hours, which is the maximum daily amountwith other drugs containing acetaminophen3 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 daysfever gets worse or lasts more than 3 daysnew symptoms occurredness or swelling is presentThese 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 dateTAMPER 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 1-800-406-7984

* Please review the disclaimer below.