FDA label 989d3dd3-a202-42f3-b050-caffc1f392f4

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
41f044c5-ad3c-4f31-8944-f7127fdc8240
SPL ID
989d3dd3-a202-42f3-b050-caffc1f392f4
Version
8
Effective date
2021-08-17
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 05:13:06

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: with other drugs containing acetaminophen more than 12 caplets in 24 hours, which is the maximum daily amount 3 or more alcoholic drinks every day 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 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 pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients for children under 12 years of age with any other product containing diphenhydramine, even one used on skin (Nighttime Cold & Flu only) Ask a doctor before use if you have heart disease liver disease thyroid disease diabetes trouble urinating due to an enlarged prostate gland high blood pressure persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (Daytime Severe Cold only) cough that occurs with too much phlegm (mucus) (Daytime Severe Cold only) a breathing problem such as emphysema or chronic bronchitis (Nighttime Cold & Flu only) glaucoma (Nighttime Cold & Flu only) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (Nighttime Cold & Flu only) When using this product do not exceed recommended dosage excitability may occur, especially in children (Nighttime Cold & Flu only) marked drowsiness may occur (Nighttime Cold & Flu only) avoid alcoholic drinks (Nighttime Cold & Flu only) alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime Cold & Flu only) be careful when driving a motor vehicle or operating machinery (Nighttime Cold & Flu only) Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur persistent cough lasts for more than one week, tends to recur, or is accompanied by fever, rash or persistent headache (Daytime Severe Cold only) These could be signs of a serious condition. 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 (1-800-222-1222) right away. Quick 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.