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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.