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| Product NDC Code | 53185-002 | ||||
|---|---|---|---|---|---|
| Drug Name | Clear choice extra strength pain reliever |
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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 | Athlete's Needs, 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 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) Do not use more than 10 days unless directed by a doctor adults and children 12 years and over: take two tablets every 4 to 6 hours. Do not take more than 8 tablets in 24 hours. children under 12 years: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients corn starch, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
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 temporary relief of minor aches and pains associated with common cold headache toothache muscular aches backache minor pain of arthritis premenstrual and menstrual cramps temporarily reduces fever
Purpose
Information about the drug product’s indications for use.Purposes Pain reliever/fever reducer
Spl product data elements
Usually a list of ingredients in a drug product.Clear Choice Extra Strength Pain Reliever ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN STARCH, CORN HYPROMELLOSES POLYETHYLENE GLYCOL, UNSPECIFIED STEARIC ACID TITANIUM DIOXIDE POVIDONE SODIUM STARCH GLYCOLATE TYPE A CORN micro-filmed coated white AZ235 round, standard convex
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 Clear Choice Extra Strength PAIN RELIEVER ACETAMINOPHEN PAIN & FEVER RELIEF CONTAINS NO ASPIRIN CAFFEINE FREE Compare to Extra Strength Tylenol (R) See new warnings information 100 Tablets 500 mg Each Questions? Contact A.N.I. Toledo OH Manufactured for A.N.I. Toledo OH 436253 Acetaminophen 500mg Acetaminophen 500mg
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 you have 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 you are taking 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 (1-800-222-1222) immediately. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms. Do not exceed recommended dosage.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store between 59º-86ºC (15º-30ºF) do not use if imprinted safety seal under cap is broken or missing
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 800-326-8147
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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 adult takes more than 4,000mg of acetaminophen 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.
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