Drug Facts
Active ingredients (in each caplet)
Acetaminophen 500 mg*
Diphenhydramine HCl 25 mg**
Purpose
*Pain reliever
**Nighttime sleep aid
Uses
Temporary relief of occasional headaches, minor aches, and pains accompanying sleeplessness.
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur with this product if you take:
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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
- 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
Do not use
- with other products 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 other products containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- liver disease
- asthma
- breathing problems such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urinating due to an enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
avoid alcoholic beverages
do not drive a motor vehicle or operate machinery. This product will cause drowsiness.
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.
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- new symptoms occur
- redness or swelling is present
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children.
Directions
- do not exceed recommended dose
- adults and children 12 years of age and over: take 2 caplets at bedtime. Do not take more than 2 caplets in 24 hours.
- children under 12 years of age: do not use this product in children under 12 years of age. This will provide more than the recommended dose (overdose) and may cause liver damage.
Other information
- store at room temperature 15°-30°C (59°-86°F), avoid high humidity and excessive heat
- do not use if imprinted safety seal under cap is broken or missing
Inactive ingredients
FD&C Blue #1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG), polyvinyl alcohol, polyvinylpyrrolidone, sodium carboxymethyl starch, starch, stearic acid, talc, titanium dioxide.