Drug Facts
Active ingredients (in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Purposes
Pain reliever
Nighttime sleep-aid
Uses
- temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
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:
If a skin reaction occurs, stop use and seek medical help right away.
- skin reddening
- blisters
- rash
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 are allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if you have
- liver disease
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking
- the blood thinning drug warfarin
- 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
These could be signs of a serious condition.
- 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
- redness or swelling is present
- any new symptoms appear
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
Overdose warning:
Taking more than the recommended dose can cause serious health problems. 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.
Directions
- do not take more than directed(see overdose warning)
- adults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor
- do not give to children under 12 years of age
Other information (2 caplets)
- store at 25°C (77°F)
Other information (24 and 50 caplets)
- store at 25°C (77°F)
- close cap tightly after use
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
Questions?
1-800-455-7139
Additional Information (2 caplets)
TAMPER-EVIDENT FEATURE: DO NOT USE IF PACKET IS DAMAGED OR OPEN
Fold Back And Tear To Open Or Use Scissors
Dist. by: GSKConsumer Healthcare,Warren, NJ 07059
Trademarks owned or licensed by GSK.
©2021 GSK or licensor.
Additional Information ( (24 and 50 caplets)
Tamper-Evident Feature:Do not use if printed inner safety seal under cap is broken or missing.
READ AND KEEP CARTON FOR COMPLETE INFORMATION
Dist. by: GSKConsumer Healthcare
Warren, NJ 07059
Trademarks owned or licensed by GSK.
©2021 GSK or licensor.