FDA label c6132271-8ef9-4f4c-e053-2995a90a42a3

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
d46090ad-63c5-4161-a4ea-5bcd98ff25ce
SPL ID
c6132271-8ef9-4f4c-e053-2995a90a42a3
Version
2
Effective date
2021-07-01
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:01:09

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 products contains acetaminophen Severe liver damage may occur if adult takes more than 6 doses in 24 hours, which is the maximum daily amount child takes more than 6 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product Do not give to children under 3 years of age or use for more than 10 days unless directed by a physician. Stop Use and ask a Doctor if you have liver disease pain, cough or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur you have a breathing problem such as emphysema or chronic bronchitis you have glaucoma or difficulty in urination due to enlargement of the prostate gland you have shortness of breath, asthma, heart disease, high blood pressure, thyroid disease, diabetes Ask a Doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. May cause excitability especially in children. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when driving motor vehicle or operating machinery. Precaution this product contains FD&C Yellow #5 (Tartrazine) as color additive. Do Not Use If you are not 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 pharmacist before taking this product 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 you are allergic to acetaminophen or any of the inactive ingredients in the product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor if you are taking sedatives or tranquilizers, without first consulting your doctor. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose Warning taking more than recommended dose (overdose) may cause liver damage. In case of accidental overdose, contact a physician or 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.

Reported adverse events (FAERS/openFDA)#

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