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Drug Facts


Active ingredient (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25mg


Purposes

Pain RelieverNighttime Sleep Aid


Uses

Temporary relief of occasional headaches and minor aches with 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 everyday while using this product

When using this prodcut

  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.


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 on skin
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you are

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

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 more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.


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.(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.


Directions

               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 this adult product in children under 12 years of age: this will provide more than the     

               recommended dose(overdose) and may cause liver damage.    

  • Do not take more than directed(see overdose warning)

Other information

  • Store at room temperature

Inactive ingredients

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.


Questions?

If you have any questions or comments. or to report  an adverse event, please contact (xxx) xxx-xxxx.