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IMPRINT: L484     SHAPE: capsule
    COLOR: white

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acetaminophen 500 mg / diphenhydramine hydrochloride 25 mg oral tablet - l437 pm oval blue

acetaminophen 500 mg - l484 oval white

acetaminophen 500 mg oral tablet - l484 oval white

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Active Ingredient (in Each Caplet) (for Pain Relief)


Acetaminophen 500 mg

Active Ingredient (in Each Caplet) (for Pain Relief Pm)


Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose (for Pain Relief)


Pain reliever/fever reducer

Purpose (for Pain Relief Pm)


Pain reliever

Nighttime sleep aid

Uses (for Pain Relief)

  • •temporarily relieves minor aches and pains due to:
  • •the common cold
  • •headache
  • •backache
  • •minor pain of arthritis
  • •toothache
  • •muscular aches
  • •premenstrual and menstrual cramps
  • •temporarily reduces fever

Uses (for Pain Relief Pm)


temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings (for Pain Relief)


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:
  • •skin reddening
  • •bulers
  • •rash

If a skin reaction occurs, stop use and seek medical help right away.

Warnings (For Pain Relief PM)


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:
  • •skin reddening
  • •bulers
  • •rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use (For Pain Relief)

  • •with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • •if you have ever had an allergic reaction to this product or any of its ingredients

Do not use (For Pain Relief PM)

  • •in children under 12 years of age
  • •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
  • •if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have (For Pain Relief)


liver disease

Ask a doctor before use if you have (For Pain Relief PM)

  • •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 (For Pain Relief)


taking the blood thinning drug warfarin

Ask a doctor or pharmacist before use if you are (for Pain Relief PM)

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

When using this product (For Pain Relief PM)
  • •drowsiness will occur
  • •avoid alcoholic drinks
  • •do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if (For Pain Relief)

  • •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.

Stop use and ask a doctor if (For Pain Relief PM)

  • •sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
  • •pain gets worse or lasts more than 10 days
  • •fever gets worse or lasts more than 3 days
  • •redness or swelling is present
  • •new symptoms occur

These could be signs of a serious condition.

If pregnant or breast-feeding, (For Pain Relief)


ask a health professional before use.

If pregnant or breast-feeding, (For Pain Relief PM)

Keep out of reach of children. (For Pain Relief)


Overdose warning: 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.

Keep out of reach of children. (For Pain Relief PM)

Directions (for Pain Relief)

  • •do not take more than directed (see overdose warning)
  • •Adults and children 12 years and over:
  • •take 2 caplets every 6 hours while symptoms last
  • •do not take more than 6 caplets in 24 hours, unless directed by a doctor
  • •do not use for more than 10 days unless directed by a doctor

Children under 12 years: ask a doctor

Directions (for Pain Relief Pm)

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

Other Information (for Pain Relief And Pain Relief Pm)

  • •store at 20-25°C (68-77°F)

Inactive Ingredients (for Pain Relief)


carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

*may contain one or more of these ingredients

Inactive Ingredients (for Pain Relief Pm)


carnauba wax, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments? (for Pain Relief And Pain Relief Pm)


1-800-719-9260

Principal Display Panel


Compare to the Active Ingredient in Extra Strength Tylenol® Caplets

Extra Strength

PAIN RELIEF

PAIN RELIEVER - FEVER REDUCER

Acetaminophen

For Adults

Actual Size

See New Warnings

100 CAPLETS 500 mg Each

VALUE PACK - DAY & NIGHT RELIEF

Compare to the Active Ingredients in Extra Strength Tylenol® PM Caplets

Extra Strength

PAIN RELIEF PM

PAIN RELIEVER - NIGHTTIME SLEEP-AID

Acetaminophen

Diphenhydramine HCl

Actual Size

For Adults

Non-Habit Forming

See New Warnings

100 CAPLETS

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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