DRUG FACTS
Drug Labeling and Warnings
Drug Details [pdf]
ACETAMINOPHEN PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet, coated
McKesson (Health Mart)
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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DRUG FACTS
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings
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
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.
- with any other product containing diphenhydramine, even one used on skin
- in children under 12 years of age
Ask a doctor before use if you have
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- glaucoma
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- drowsiness will occur
- avoid alcoholic drinks
- do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
Directions
- do not take more than directed (see overdose warning)
- adults and children 12 years and over: take 2 geltabs at bedtime. Do not take more than 2 geltabs of this product in 24 hours.
- children under 12 years: do not use
Other information
- store at room temperature 15º-30ºC (59º-86ºF)
- avoid high humidity and excessive heat
Inactive ingredients
corn starch, croscarmellose sodium*, D&C red #27 aluminum lake, edible black ink, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, purified water, silicon dioxide, sodium starch glycolate*, stearic acid, titanium dioxide
*contains one or more of these ingredients
Principal Display Panel
compare to extra strength tylenol® pm active ingredients†
extra strength acetaminophen pm
acetaminophen, 500 mg
diphenhydramine HCl, 25 mg
pain reliever nighttime sleep-aid
geltabs
†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® PM.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Another Quality Product Distributed by McKesson
One Post Street, San Francisco, CA 94104
| ACETAMINOPHEN PM
EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet, coated |
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| Labeler - McKesson (Health Mart) (177667227) |
| Registrant - P & L Development, LLC (800014821) |
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