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| Product NDC Code | 58602-873 | ||||||||||||||||||||||||||||
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| Drug Name | Acetaminophen |
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| Type | Generic | ||||||||||||||||||||||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||||||||||||||||||||||
| Dosage Form | TABLET, EXTENDED RELEASE | ||||||||||||||||||||||||||||
| RxCUI drug identifier | 1148399 | ||||||||||||||||||||||||||||
| Application Number | ANDA207229 | ||||||||||||||||||||||||||||
| Labeler Name | Aurohealth LLC | ||||||||||||||||||||||||||||
| Packages |
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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 and children 12 years and over 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. children under 12 years do not use
| adults and children 12 years and over |
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| children under 12 years |
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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: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramp headache the common cold 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 (250 Tablet Bottle) AUROHEALTH TO OPEN: 1. PUSH DOWN NDC 58602-873-36 2. TURN CAP DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 8 HOUR MUSCLE ACHES & PAIN Acetaminophen Extended-Release Tablets USP 650 mg Pain Reliever/Fever Reducer For up to 8 Hours Relief of Minor Muscle Aches & Pain 250 Extended-release tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (250 Tablet Bottle)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (250 Tablets Container Carton) AUROHEALTH NDC 58602-873-36 DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 8 HOUR MUSCLE ACHES & PAIN Acetaminophen Extended-Release Tablets USP 650 mg Pain Reliever/Fever Reducer For Up to 8 Hours Relief of Minor Muscle Aches & Pain 250 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