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| Product NDC Code | 55758-012 | ||||
|---|---|---|---|---|---|
| Drug Name | Vitapirena |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | GRANULE, FOR SOLUTION | ||||
| RxCUI drug identifier | 2668206 | ||||
| Application Number | M013 | ||||
| Labeler Name | Pharmadel LLC | ||||
| 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 & Purposes Active ingredient (in each packet) Purposes Acetaminophen 500 mg Pain reliever/ fever reducer
| Pain reliever/ fever reducer |
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 Age Dose adults and children 12 years of age and over take one (1) packet, every 4 hours. Do not exceed; adults 8 packets or children 5 packets in 24 hours children under 12 years of age do not use
| adults and children 12 years of age and over | take one (1) packet, every 4 hours. Do not exceed; |
| children under 12 years of age |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients chamomile lemon flavor, citric acid monohydrate, fructose, povidone k30, silicon dioxide, sodium bicarbonate, sucralose, water
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 For the temporary relief of minor aches and pains associated with sore throat headache the common cold/ flu muscular aches backache minor pain from arthritis and to reduce fever
Purpose
Information about the drug product’s indications for use.Active ingredient (in each packet) Purposes Acetaminophen 500 mg Pain reliever/ fever reducer
| Pain reliever/ fever reducer |
Spl product data elements
Usually a list of ingredients in a drug product.Vitapirena ACETAMINOPHEN ANHYDROUS CITRIC ACID SODIUM BICARBONATE POVIDONE K30 WATER FRUCTOSE SUCRALOSE ACETAMINOPHEN ACETAMINOPHEN SILICON DIOXIDE +Chamomile
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 PDP Vitapirena CL
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: PHARMADEL LLC. New Castle, DE 19720
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 is a child with pain from 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 the user 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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if allergic to acetaminophen or any other of the inactive ingredients in this product
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 an accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information each 5g packet contains: 1 78 mg sodium store at room temprature 77-86° F (25-30° C)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? +1-866--359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com
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 adult’s pain gets worse or lasts more than 10 days child’s pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, 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 8 packets in 24 hours, which is the maximum daily amount for this product child takes more than 5 packets in 24 hours with other drugs containing acetaminophen adult has 3 or more alcoholic drinks everyday while using this product Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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 allergic to acetaminophen or any other of the inactive ingredients in this product Ask a doctor before use if the user has liver disease is a child with pain from arthritis Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin Stop use and ask a doctor if adult’s pain gets worse or lasts more than 10 days child’s pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. In case of an accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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