acetaminophen pm extra strength
Medically reviewed on June 15, 2018
Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Sam's West Inc
NDC Code: 68196-556
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.
(in each gelcap)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
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:
- with other drugs containing acetaminophen
- more than 4,000 mg of acetaminophen in 24 hours
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
- 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
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
- drowsiness will occur
- avoid alcoholic beverages
- do not drive a motor vehicle or operate machinery
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- 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.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
do not take more than directed
- adults and children 12 years and over
- take 2 gelcaps at bedtime
- do not take more than 2 gelcaps of this product in 24 hours
- children under 12 years: do not use
- use by expiration date on package
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- avoid high humidity
ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide
Compare to Extra Strength Tylenol® PM active ingredients*
acetaminophen 500 mg/
diphenhydramine HCl 25 mg/
nighttime sleep aid
• Relieves headache, minor aches
& pains accompanied
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® PM.
DISTRIBUTED BY: SAM'S WEST, INC., BENTONVILLE, AR72716
100% MONEY BACK GUARANTEE
SUPERIOR QUALITY AND PERFORMANCE
we would like to hear from you with any comments or suggestions.
In the continental U.S. or Canada, you can call us at 1-800-426-9391
from 8:30 a.m. to 4:00 p.m. EST Monday-Friday.
acetaminophen, diphenhydramine hcl tablet
|Labeler - Sam's West Inc (051957769)|
|LNK International, Inc.||038154464||PACK(68196-556)|
|LNK International, Inc.||868734088||MANUFACTURE(68196-556), PACK(68196-556)|
|LNK International, Inc.||832867837||PACK(68196-556)|
|LNK International, Inc.||967626305||PACK(68196-556)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.