Drug Facts
Active ingredients (in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
The following Structured Product Label (SPL) was submitted to the FDA by Leader/ Cardinal Health 110, Inc. for the product Acetaminophen, Diphenhydramine Hydrochloride (NDC 70000-0411). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, otc - purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Purpose
Pain reliever
Nighttime sleep-aid
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 4,000 mg of acetaminophen in 24 hours
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product
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.
Do not use
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask a doctor if
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: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
store at room temperature
croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, mineral oil, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin
(800) 231-4670
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® PM Extra Strength.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
DIST BY CAH, DUBLIN, OH 43017
1-800-200-6313
© 2018 Cardinal Health
100% Money Back Guarantee
Return to place of purchase if not satisfied
LEADER TM
NDC 7000-0411-2
Extra Strength Acetaminophen PM
Acetaminophen, 500mg
Diphenhydramine HCl, 25mg
Pain Reliever/Nighttime Sleep-Aid
COMPARE TO TYLENOL ® PM EXTRA STRENGTH active ingredients*
50 Caplets
* Please review the disclaimer below.