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| Product NDC Code | 53345-019 | ||||||
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| Drug Name | Pain relief extra strength |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | CAPSULE, LIQUID FILLED | ||||||
| RxCUI drug identifier | 198439 | ||||||
| Application Number | part343 | ||||||
| Labeler Name | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | ||||||
| Packages |
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Overdosage of Pain Relief Extra Strength
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.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.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each capsule) 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 take more than directed (see Overdose warning ) Adults and children 12 years of age and over take 2 softgels every 4 to 6 hours while symptoms last do not take more than 6 softgels in 24 hours unless directed by a doctor do not take more than 10 days unless diredted by doctor Children 12 years of age ask a doctor
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Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink Manufactured by: Humanwell PuraCap Pharmaceutical (Wuhan) Ltd. Wuhan, Hubei 430206, China
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: the common cold headache backache minor pain of arthritis toothache muscular aches 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.Pain Relief Extra Strength ACETAMINOPHEN FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SORBITOL ACETAMINOPHEN ACETAMINOPHEN oblong PC24
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 - Shipping Label ACETAMINOPHEN CAPSULES, 500 mg Quantity : 3000 Capsules NDC. No : 53345-019-01 IMPORTANT: Inspect immediate upon receipt. This is a bulk shipment intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING" Shipping Label
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
ACETAMINOPHEN CAPSULES, 500 mg Quantity : 3000 Capsules NDC. No : 53345-019-01 IMP ORTANT: Inspect immediate upon receipt. This is a bulk shipment intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING" Shipping Label
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 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 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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you have 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.
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.
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 room temperature 15°-30°C (59°-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 Warnings Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 softgels (3,000 mg) in 24 hours. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if the user has liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. 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. 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.
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