FDA label 96a10d7d-302f-a3fa-e053-2995a90ab54f

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
480fafe3-f644-4813-8150-de5b0de6e8df
SPL ID
96a10d7d-302f-a3fa-e053-2995a90ab54f
Version
3
Effective date
2019-11-05
Source export date
2026-08-01
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/2026-08-01/054d07cb7b0dcd436e53c5bdecbb921b48860de8ff372c4a586941aa9821a276/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:21:21

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 Children under 12 years of age : Do not give to children under 12 years of age. Liver Warning : This product contains acetaminophen. Severe liver damage may occur if you take: • more than 2 tablets in 24 hours • with other drugs containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. • 3 or more alcoholic drinks every day while using this product Caution: This product will cause drowsiness. • do not drive a motor vehicle or operate machinery after use. • avoid alchoholic beverages while taking this product • do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor • if sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. Do not use : • more than the recommended dose • do not take this product unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate glandwith any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns. • with any other product containing diphenhydramine, even one used on the skin • for more than 10 days for pain unless directed by a doctor • for more than 3 days for fever unless directed by a doctor. • when using this product do not exceed recommended dose. Stop use and ask a doctor if: • symptoms do not improve within 7 days or are accompanied by a fever • pain or fever persists or gets worse • new symptoms occur • redness or swelling is present • nervousness, dizziness or sleeplessness occur Ask a doctor before use if you have : • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland. 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