Indications and 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
Vitapirena
- Manufacturer
- Pharmadel LLC
- Effective date
- 2025-12-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:29:01
Label at a glance#
ProductVitapirena
Active ingredientACETAMINOPHEN
Label structure9 sections
Dosage and administration
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
Contacts and useful links#
Websitewww.pharmadel.com
www.pharmadel.com
www.pharmadel.comLabel contents#
Full prescribing information#
Active ingredient & Purposes
OTC - PURPOSE SECTION
| 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
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.
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 at room temprature 77-86° F (25-30° C)
Inactive ingredients
chamomile lemon flavor, citric acid monohydrate, fructose, povidone k30, silicon dioxide, sodium bicarbonate, sucralose, water
Questions?
+1-866--359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com
Distributed by:
PHARMADEL LLC.
New Castle, DE 19720
Principal Display Panel
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55758-012-05 | Vitapirena | 5 in 1 BOX | GRANULE, FOR SOLUTION | 5 | 3 | |
| 55758-012-05 | Vitapirena | 1 in 1 PACKET | GRANULE, FOR SOLUTION | 1 | 3 |
Products#
Every source-derived product name is available through these pages.
- Vitapirena
- ACETAMINOPHEN
- ANHYDROUS CITRIC ACID
- SODIUM BICARBONATE
- POVIDONE K30
- WATER
- FRUCTOSE
- SUCRALOSE
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55758-012 | 55758-012-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| WATER | 059QF0KO0R | IACT |
| FRUCTOSE | 6YSS42VSEV | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Vitapirena | ACETAMINOPHEN | Pharmadel LLC | 0547bc1f-d000-f5a6-e063-6294a90ac73d | 2025-12-22 | Warnings | 55758-012-05 55758-012 55758001205 468fc0a7-2a13-5c91-e063-6294a90af9a2 0547bc1f-d000-f5a6-e063-6294a90ac73d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.