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| Product NDC Code | 68599-4681 | ||||
|---|---|---|---|---|---|
| Drug Name | Acetaminophen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| Application Number | part343 | ||||
| Labeler Name | McKesson | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Acetaminophen 500 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 use more than directed Adults and children: (12 years and older) Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours. Children under 12 years: Do not give to children under 12 years of age
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*. * may contain
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 For the temporary relief of minor aches and pains associated with headache muscular aches minor arthritis pain common cold toothache menstrual cramps For the reduction of 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 Pain reliever TITANIUM DIOXIDE STEARIC ACID STARCH, CORN GLYCOLIC ACID ACETAMINOPHEN ACETAMINOPHEN HYPROMELLOSES MICROCRYSTALLINE CELLULOSE MALTODEXTRIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE SODIUM STARCH GLYCOLATE TYPE A POTATO FR;33
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.NDC# 68599-4681-3 McKesson Acetaminophen Tablets 500mg Non-Aspirin Used to reduce fever / Temporarily relieves aches and pains 2 per Pack / 250 packs per Box MFR# 82468 82468 each 82468 box 82468 case
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store at room temperature 59º-86ºF (15º-30ºC) tamper-evident sealed packets do not use any opened or torn packets
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-800-777-4908
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.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. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor 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 using and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swelling is present If pregnant or breast-feeding, ask a health professional before use.
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 8 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