Overview
- Active ingredient
- Diphenhydramine, Acetaminophen
- Established class
- Histamine-1 Receptor Antagonist
- Mechanism class
- Histamine H1 Receptor Antagonists
- Route
- Oral
- Label date
- 2025-12-19
Indications and usage
Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Purpose
Pain reliever Nighttime sleep aid
Dosage and administration
Directions
- do not take more than directed (see overdose warning) adults and children 12 years and over
- take 2 caplets at bedtime
- do not take more than 2 caplets of this product in 24 hours children under 12 years
- do not use
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
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
- 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 have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if
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
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
this product
- drowsiness will occur
- avoid alcoholic drinks
- do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
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
- redness or swelling is present
- new symptoms occur These could be signs of a serious condition
Overdosage
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.
Pregnancy or breast-feeding
If pregnant or breast-feeding, ask a health professional before use
Active ingredient (label)
s (in each caplet) Acetaminophen USP, 500 mg Diphenhydramine HCl USP, 25 mg
Inactive ingredients
s carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k-30, pregelatinized starch, stearic acid, titanium dioxide
Storage and handling
Other information
- store between 20-25°C (68-77°F). See USP Controlled Room Temperature.
- see end panel for lot number and expiration date
Keep out of reach of children
of children Keep out of reach of children