SanaTos X Children

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)

Brand name
SanaTos X Children
Generic name
ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI
Manufacturer
Pharmadel LLC
Product type
HUMAN OTC DRUG
SPL set ID
1fc1408c-c540-39ab-e063-6394a90aa477
SPL ID
1fc1408c-c541-39ab-e063-6394a90aa477
Version
1
Effective date
2024-08-15
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 05:14:13
Harmonized routes table
Harmonized routes
ORAL

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 your child takes more than 5 doses in 24 hours , which is the maximum daily amount with other drugs containing acetaminophen 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. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, nausea, and vomiting, consult 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. in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before taking product. Ask a doctor or pharmacist before use if your child is aking the blood thinning drug warfarin. Ask a doctor before use if your child has liver disease a cough that is accompanied with excessive phlegm (mucus) a persistent or chronic cough such as occurs with asthma heart disease high blood pressure thyroid disease diabetes When using this product do not exceed recommended dosage. do not use more than directed Stop use and ask a doctor if pain, cough, or nasal congestion gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur nervousness, dizziness, or sleeplessness occur 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 even if you do not notice any signs or symptoms.

Reported adverse events (FAERS/openFDA)#

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