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Acetaminophen - Medication Information

Product NDC Code 58602-730
Drug Name

Acetaminophen

Type Generic
Active Ingredients
Acetaminophen 650 mg/1
Route ORAL
Dosage Form TABLET, EXTENDED RELEASE
RxCUI drug identifier 1148399
Application Number ANDA207229
Labeler Name Aurohealth LLC
Packages
Package NDC Code Description
58602-730-07 1 bottle in 1 carton (58602-730-07) / 24 tablet, extended release in 1 bottle
58602-730-14 1 bottle in 1 carton (58602-730-14) / 50 tablet, extended release in 1 bottle
58602-730-21 1 bottle in 1 carton (58602-730-21) / 100 tablet, extended release in 1 bottle
58602-730-28 1 bottle in 1 carton (58602-730-28) / 225 tablet, extended release in 1 bottle
58602-730-29 150 tablet, extended release in 1 bottle (58602-730-29)
58602-730-34 200 tablet, extended release in 1 bottle (58602-730-34)
58602-730-35 225 tablet, extended release in 1 bottle (58602-730-35)
58602-730-36 1 bottle in 1 carton (58602-730-36) / 250 tablet, extended release in 1 bottle
58602-730-40 500 tablet, extended release in 1 bottle (58602-730-40)
58602-730-41 1000 tablet, extended release in 1 bottle (58602-730-41)
58602-730-44 400 tablet, extended release in 1 bottle (58602-730-44)
58602-730-67 290 tablet, extended release in 1 bottle (58602-730-67)
58602-730-76 325 tablet, extended release in 1 bottle (58602-730-76)
58602-730-94 100 tablet, extended release in 1 bottle (58602-730-94)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Drug Facts Active ingredient (in each extended-release tablet) Acetaminophen USP 650 mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions do not take more than directed (see overdose warning). Adults: take 2 tablets every 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 tablets in 24 hours do not use for more than 10 days unless directed by a doctor. Under 18 years of age: ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin Questions or comments? call 1-855-274-4122 Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road, East Windsor, NJ 08520 Made in India Code: TS/DRUGS/22/2009

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever

Purpose

Information about the drug product’s indications for use.
Purpose Pain reliever/fever reducer

Spl product data elements

Usually a list of ingredients in a drug product.
Acetaminophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN SILICON DIOXIDE HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED STARCH, CORN SODIUM STARCH GLYCOLATE TYPE B POTATO TITANIUM DIOXIDE TRIACETIN White to Off-White Caplet I;06

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (225 Tablets Bottle) AUROHEALTH TO OPEN: 1. PUSH DOWN NDC 58602-730-28 2. TURN CAP DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 8 HOUR ARTHRITIS PAIN Acetaminophen Extended-Release Tablets USP 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain 225 Extended-release tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (250 Tablet Bottle) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (225 Tablets Container Carton) AUROHEALTH NDC 58602-730-28 * Compare to the Active Ingredient in Tylenol ® 8 HR Arthritis Pain DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 8 HOUR ARTHRITIS PAIN Acetaminophen Extended-Release Tablets USP 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain 225 Extended-release tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (250 Tablets Container Carton)

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
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

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
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.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
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.

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at 20 o to 25 o C (68 o to 77 o F). Avoid excessive heat 40 o C (104 o F). do not use if carton is opened or foil inner seal is broken Meets USP dissolution test 3

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 tablets 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 Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API