FDA label e95ec98e-1a21-ddd9-e053-2a95a90af95e

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
81f30812-60c2-65c0-e053-2991aa0afed6
SPL ID
e95ec98e-1a21-ddd9-e053-2a95a90af95e
Version
10
Effective date
2022-09-23
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 05:13:48

Warnings cross-check#

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

Warnings sections page 1 of 2 · 7 matching rows.

warnings

Acetaminophen 160 mg / 5 mL Major Pharmaceuticals 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 allergic to acetaminophen or any other inactive ingredients in this product ____________________________________________________________________________ Ask a doctor before use if the user - has liver disease - is pregnant or breast-feeding ____________________________________________________________________________ Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin ____________________________________________________________________________ Stop use and ask a doctor if - pain gets worse or lasts more than 10 days - new symptoms occur - fever gets worse or lasts more than 3 days - redness or swelling is present These could be signs of a serious condition

warnings

Diphenhydramine HCl 12.5 mg/5 mL Major Pharmaceuticals - For Institutional Use Only Warnings Do not use in neonates or premature infants if pregnant or breast-feeding if hypersensitive to diphenhydramine HCl and other similar antihistamines with any other product containing diphenhydramine, even one used on skin to make a child sleepy ___________________________________________________________________ Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis a sodium restricted diet trouble urinating due to an enlarged prostate gland ___________________________________________________________________ Ask a doctor or pharmacist before use if taking tranquilizers or sedatives ___________________________________________________________________ When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children ___________________________________________________________________

warnings

Diphenhydramine HCl 10 mg/ 10 mL Major Pharmaceuticals - For Institutional Use Only Warnings Do not use • in neonates or premature infants • if pregnant or breast-feeding • if hypersensitive to diphenhydramine HCl and other similar antihistamines • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy ___________________________________________________________________ Ask a doctor before use if you have • glaucoma • a breathing problem such as emphysema or chronic bronchitis • a sodium restricted diet • trouble urinating due to an enlarged prostate gland ___________________________________________________________________ Ask a doctor or pharmacist before use if • taking tranquilizers or sedatives ___________________________________________________________________ When using this product • marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children

warnings

Acetaminophen 325 mg / 5 mL Major Pharmaceuticals 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 allergic to acetaminophen or any other inactive ingredients in this product ____________________________________________________________________________ Ask a doctor before use if the user - has liver disease - is pregnant or breast-feeding ____________________________________________________________________________ Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin ____________________________________________________________________________ Stop use and ask a doctor if - pain gets worse or lasts more than 10 days - new symptoms occur - fever gets worse or lasts more than 3 days - redness or swelling is present These could be signs of a serious condition ____________________________________________________________________________

Reported adverse events (FAERS/openFDA)#

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