Vitapirena Granule, For Solution
FDA Label NDC 55758-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Vitapirena (NDC 55758-012). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient & purposes, otc - purpose, uses, warnings, do not use, ask a doctor before use if the user, ask a doctor or pharmacist before use if the user is, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredient (in each packet) | Purposes |
| Acetaminophen 500 mg | Pain reliever/ fever reducer |
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
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
- 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
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.
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 |
Other Information
- each 5g packet contains: 1 78 mg sodium
- store between 77-86° F (25-30° C)
Inactive Ingredients
chamomile lemon flavor, citric acid monohydrate, fructose, povidone k30, silicon dioxide, sodium bicarbonate, sucralose, water
Questions?
+1-877-798-5944 (M-F) 9 AM - 5 PM EST or pharmadel.com
Distributed By:
PHARMADEL LLC.
New Castle, DE 19720
Principal Display Panel
Pdp Vp (Vitapirena Pdp)
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