Acetaminophen PM Extra Strength
Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: BJWC (Berkley & Jensen / BJ's)
NDC Code: 68391-161
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.
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Temporary relief of occasional headaches and minor aches and pains accompanying sleeplessness.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 2 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- 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 other products containing diphenhydramine, even one used on skin
- in children under 12 years of age
- if you have ever had an allergic reaction to this product or any of its ingredients
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
- drowsiness will occur
- avoid alcoholic drinks
- 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 for more than 10 days
- fever gets worse or lasts for more than 3 days
- redness or swelling is present
- new symptoms occur
ask a health care professional before use.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.
do not take more than directed (see overdose warning)
|adults and children 12 years and over||
|children under 12 years||
Do not use this adult product in children under 12 years of age, this will provide more than the recommended dose (overdose) and may cause liver damage.
- store at room temperature 15°-30°C (59°-86°F), avoid high humidity and excessive heat
*contains one or more of these ingredients
Call toll free: 1-800-934-1204 Monday-Friday 9AM-5PM EST
PAIN RELIEVER/NIGHTTIME SLEEP-AID
ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HCl 25 mg
Compare to the active ingredients of Tylenol® PM Caplets**
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 Tylenol® PM.
Distributed by BJWC
25 Research Drive
Westborough, MA 01581
acetaminophen, diphenhydramine hcl tablet, coated
|Labeler - BJWC (Berkley & Jensen / BJ's) (159082692)|
|Registrant - P and L Development of New York Corporation (800014821)|
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.