Drugplain

Vitapirena 500 mg/1

ACETAMINOPHEN · GRANULE, FOR SOLUTION · Pharmadel LLC

No Recall HistoryCurrently in Shortage
Plain English

Vitapirena is an over-the-counter pain reliever and fever reducer containing acetaminophen that comes as granules you dissolve in water before taking by mouth. Each dose contains 500 mg of acetaminophen.

Key Facts

Brand Name
Vitapirena
Generic Name
ACETAMINOPHEN
NDC Code (Product)
55758-012
Manufacturer
Pharmadel LLC
Strength
500 mg/1
Dosage Form
GRANULE, FOR SOLUTION
Route
ORAL
Marketing Status
Application #
M013
Marketing Start
10/25/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use22,386 reports
fatigue20,435 reports
drug ineffective18,155 reports
pain18,103 reports
nausea17,623 reports
headache16,714 reports
toxicity to various agents15,539 reports
dyspnoea14,575 reports
arthralgia14,309 reports
pyrexia14,271 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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

Warnings

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 appea…

Frequently Asked Questions

What is Vitapirena used for?

Vitapirena is an over-the-counter pain reliever and fever reducer containing acetaminophen that comes as granules you dissolve in water before taking by mouth. Each dose contains 500 mg of acetaminophen.

Is Vitapirena a controlled substance?

Vitapirena is not classified as a controlled substance by the DEA.

What is the generic name for Vitapirena?

The generic name for Vitapirena is ACETAMINOPHEN. There are 12 other brand versions of ACETAMINOPHEN.

What is the NDC code for Vitapirena 500 mg/1?

The NDC (National Drug Code) for Vitapirena 500 mg/1 is 55758-012, listed by Pharmadel LLC.

Product NDC

55758-012

Package NDC

55758-012-05

Other Acetaminophen Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)