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Generic: acetaminophen and diphenhydramine hcl is used for the treatment of Anxiety Disorders Infant, Newborn Infant, Premature Sleep Initiation and Maintenance Disorders Lactation Motion Sickness Nausea Rhinitis, Allergic, Perennial Sneezing Status Asthmaticus Urticaria Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain


IMPRINT: PM     SHAPE: oval
    COLOR: blue

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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:
  • skin reddening
  • bulers
  • rash

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

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
  • be careful when driving a motor vehicle or operating machinery

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
  • redness or swelling is present
  • any new symptoms appear

These could be signs of a serious condition.

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

  • store below 25°C (77°F)

Inactive Ingredients


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?


1-800-455-7139

Principal Display Panel


NDC 0135-0608-01

PANADOL

EXTRA STRENGTH

PM

ACETAMNOPHEN

Pain Reliever

DIPHENHYDRAMINE HCl

Nighttime Sleep-Aid

24 CAPLETS

Tamper-Evident Feature:Do not use if printed bottle seal (under cap) is missing or broken.

READ AND KEEP CARTON FOR COMPLETE INFORMATION

Trademarks are owned by or licensed to the GSK group of companies.

Distributed by:

GSKConsumer Healthcare, Warren, NJ 07059

©2016 GSK group of companies or its licensor.

101639XE

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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