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ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLETS


SPL UNCLASSIFIED SECTION

Drug Facts


OTC - PURPOSE SECTION

Acetaminophen 500mgPain reliever
Diphenhydramine HCl 25mgNighttime Sleep aid

Uses

for the 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 with this product if you take

  • 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 you are using this product

OTC - DO NOT USE SECTION

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 any other products containing diphenhydramine, even one used on skin
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • liver cirrhosis
  • asthma
  • breathing problems such as emphysema or chronic bronchitis
  • trouble in urinating due to an enlargement of the prostate gland
  • glaucoma

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

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

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

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 for more than 10 days
  • fever gets worse or lasts 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 professional before use.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.


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 of age and over:take 2 caplets at bedtime or as directed by a doctordo not take more than 2 caplets in a 24 hour period
children under 12 years of age: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 recommended (see overdose warning)

Other information

  • store at 20°-25°C (68°-77°F)
  • see end panel for lot number and expiration
  • each tablet contains: magnesium 0.05 mg

Inactive ingredients

FD&C blue # 1, FD&C blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol-400, pregelatinized starch, povidone, stearic acid, titanium dioxide


SPL UNCLASSIFIED SECTION

Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716