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| Product NDC Code | 51672-2117 | ||||
|---|---|---|---|---|---|
| Drug Name | Feverall adults |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | RECTAL | ||||
| Dosage Form | SUPPOSITORY | ||||
| RxCUI drug identifier | 198443, 209364 |
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| Application Number | NDA018337 | ||||
| Labeler Name | Taro Pharmaceuticals U.S.A. Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each rectal suppository) Acetaminophen, USP 650 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 remove wrapper carefully insert suppository well up into the rectum adults and children 12 years and older: 1 suppository every 4 to 6 hours while symptoms last do not exceed 6 suppositories in any 24-hour period children under 12 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients glycerol monostearate, hydrogenated vegetable oil, polyoxyethylene stearate, polysorbate 80
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 reduces fever relieves minor aches, pains, and headache
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.Feverall Adults Acetaminophen Acetaminophen Acetaminophen glyceryl monostearate hydrogenated palm kernel oil PEG-100 stearate polysorbate 80
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 - 50 Suppository Carton ADULTS' ages 12 years & older FeverAll ® ACETAMINOPHEN SUPPOSITORIES Pain Reliever/Fever Reducer NOT FOR RETAIL SALE NDC 51672-2117-4 RECTAL SUPPOSITORY* *actual size Doctor Recommended 50 Rectal Suppositories 650 mg each Principal Display Panel - 50 Suppository Carton
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
Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532
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. 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 in children under 12 years. 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. If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical in case of overdose for adults and 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? call 1-866-923-4914
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.If a skin reaction occurs, stop use and seek medical help right away. For rectal use only.
Stop use and ask a doctor if fever lasts more than 3 days (72 hours), or recurs. pain gets worse or lasts more than 10 days. new symptoms occur. redness or swelling is present in the painful area. These may 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 2°-27°C (35°-80°F) do not use if imprinted suppository wrapper is opened or damaged
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 an adult or child 12 years and older takes more than 6 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen an adult takes 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. For rectal use only. Do not use in children under 12 years. 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 you have liver disease. you are taking the blood thinning drug warfarin. Stop use and ask a doctor if fever lasts more than 3 days (72 hours), or recurs. pain gets worse or lasts more than 10 days. new symptoms occur. redness or swelling is present in the painful area. These may be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical in case of overdose for adults and 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