FDA label 851faaa4-db63-476e-82c2-39f0a873051e

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
c4e0962d-b539-47bb-bfdc-11ad7b079cf1
SPL ID
851faaa4-db63-476e-82c2-39f0a873051e
Version
4
Effective date
2022-12-31
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:12:49

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: • More than 8 tablets in 24 hours, which is the maximum daily amount • With other drugs containing acetaminophen • 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. Do Not Use: • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacists before using this product. • For more than 3 days for fever unless directed by a doctor • With any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • For more than 10 days for pain unless directed by a doctor Ask a doctor before use if you have: • Liver disease • Heart disease • High blood pressure • Thyroid disease • Diabetes • Difficulty in urination due to enlargement of the prostate gland Ask a doctor before use if you are taking the blood thinning drug warfarin. When using this product do not exceed recommended dose Stop use and ask doctor if: • New symptoms occur • Redness or swelling is present • Pain gets worse or lasts for more than 10 days • Fever gets worse or lasts more than 3 days • Nervousness, dizziness, or sleeplessness occurs • If cold gets worse or lasts more than 7 days If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of 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 • Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours as needed. Do not exceed 8 tablets in 24 hours, or as directed by a doctor. • Children under 12 years: Do not use this product; This will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns. Other Information Do not use if packet is torn, cut or opened • Store at room temperature • Avoid excessive heat and humidity Keep out of reach of children Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of 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. Acetaminophen 325mg Phenylephrine HCl 5mg FD&C Blue #1, Hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, starch, stearic acid

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.