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| Product NDC Code | 71399-8014 | ||||
|---|---|---|---|---|---|
| Drug Name | Acetaminophen |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 313782 | ||||
| Application Number | part343 | ||||
| Labeler Name | Akron Pharma Inc. | ||||
| 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 325 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 & children 12 years and over take 2 tablets every 4 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours do not use for more than 10 days unless directed by a doctor children 6-11 years take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours do not use for more than 5 days unless directed by a doctor child under 6 years ask a doctor
| adults & children 12 years and over |
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| children 6-11 years |
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| child under 6 years | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: colloidal silicon dioxide, microcrystalline cellulose, polacrilin potassium, propylparaben, povidone, stearic acid.
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 To reduce fever and for the temporary relief of minor aches and pains due to: •headache •muscular aches •backache •minor pain of arthritis •the common cold •toothache •premenstrual and menstrual cramps. •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 MICROCRYSTALLINE CELLULOSE POLACRILIN POTASSIUM PROPYLPARABEN POVIDONE STEARIC ACID AP325 ACETAMINOPHEN Acetaminophen ACETAMINOPHEN ACETAMINOPHEN SILICON DIOXIDE MICROCRYSTALLINE CELLULOSE POLACRILIN POTASSIUM PROPYLPARABEN POVIDONE STEARIC ACID AP325
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.325mg - Unit Dose 325 mg -100 Tablets 325mg -1000 Tablets 325 UD 325 mg-100 325 mg-1000
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if the user has has liver disease is a child with pain of arthritis
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
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 non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if the user has ever had an allergic reaction to this product or any of its ingredients.
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: Taking more than the recommended dose (overdose) may cause liver damage. 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.
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? Call toll-free 1-877-225-6999 Manufactured for Akron Pharma, Inc., 373 RT US46 W Building E, Suite 117, Fairfeld, NJ - 07004 Mfg. Lic. No: TN/DRUGS/558/1997 * This product is not manufactured or distributed by Johnson and Johnson, consumer inc., distributor of regular Tylenol Tablets.
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 (for adults) or 5 days (for children) 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.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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 temperature 15° to 30°C (59° to 86°F)
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 adult takes more than 4,000 mg of acetaminophen in 24 hours child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 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. Do not use with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if the user has ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if the user has has liver disease is a child with pain of arthritis Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin Stop use and ask a doctor if: pain gets worse or lasts more than 10 days (for adults) or 5 days (for children) 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: Taking more than the recommended dose (overdose) may cause liver damage. 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.
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