Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE CITRATE 38mg
Labeler: Bayer HealthCare LLC
NDC Code: 0280-8070
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.
Active ingredients (in each caplet) Purpose
Acetaminophen 500 mg..............................…………………...Pain reliever
Diphenhydramine citrate 38 mg…….…………………..Nighttime sleep-aid
Use for relief of occasional sleeplessness when associated with minor aches and pains from premenstrual and menstrual periods (dysmenorrhea).
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 or severe allergic reactions. Symptoms may include:
· skin reddening · blisters · rash
· hives · facial swelling · asthma (wheezing)
If a skin or general allergic reaction occurs, stop use and seek medical help right away.
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.
· in children under 12 years of age
· with any other product containing diphenhydramine, even one used
· if you have ever had an allergic reaction to this product or any of its
Ask a doctor before use if you have
· liver disease
· a breathing problem such as emphysema or chronic bronchitis
· difficulty in urination due to enlargement of the prostate gland
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 serious underlying medical illness.
· pain gets worse or lasts more than 10 days
· fever gets worse or lasts more than 3 days
· new symptoms occur
· redness or swelling is present
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 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 the recommended dose
· adults and children 12 years and older: take 2 caplets at bedtime if needed, or as directed by a doctor
· children under 12 years: do not use
Other information store at room temperature
Inactive ingredients carnauba wax, corn starch, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, povidone, propylene glycol, shellac, stearic acid, titanium dioxide
Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST)
midol pm tablet, coated
|Labeler - Bayer HealthCare LLC (785159372)|
|Bayer HealthCare LLC Consumer Care||072827066||manufacture(0280-8070), pack(0280-8070)|
Medically reviewed on Dec 10, 2018