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| Product NDC Code | 50804-328 | ||||
|---|---|---|---|---|---|
| Drug Name | Pain relief extra strength |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 198440 | ||||
| Application Number | M013 | ||||
| Labeler Name | Good Sense | ||||
| 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(s) 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 (see overdose warning) ■ adults and children 12 years and over: take 2 caplets every 6 hours while symptoms last ■ do not take more than 8 caplets in 24 hours, unless directed by a doctor ■ do not take for more than 10 days unless directed by a doctor. ■ children under 12 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients corn starch, povidone, pregelatinized starch, sodium starch glycolate, 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.Use(s) temporary relief of minor aches and pains associated with ■ common cold ■ headache ■ toothache ■ muscular aches ■ backache ■ arthritis ■ menstrual cramps ■ and 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.Pain Relief Extra Strength Acetaminophen 500 mg ACETAMINOPHEN ACETAMINOPHEN STARCH, CORN STEARIC ACID POVIDONE SODIUM STARCH GLYCOLATE TYPE A CORN AZ328
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.Principal Display Panel Pain Relief Pain Relief
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.Other information ■ do not use if imprinted safety seal under cap is broken or missing
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 liver disease
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 are 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 if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage.
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 symptoms do not improve pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present a rare sensitivity reaction occurs You may report side effects to 1-888-952-0050
Pregnancy or breast feeding
Pregnancy or Breast feedingPregnancy/Breastfeeding ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Storage ■ store between 20º-25ºC (68º-77ºF)
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 4000 mg of acetaminophen 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 Do not use if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if liver disease Ask a doctor or pharmacist before use if are taking the blood thinning drug warfarin Stop use and ask a doctor if symptoms do not improve pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present a rare sensitivity reaction occurs You may report side effects to 1-888-952-0050 Pregnancy/Breastfeeding ask a health professional before use. Keep out of reach of children In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage. Overdose Warning Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get help or contact a Poison Control Center (1-800-222-1222) right away. 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