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PANADOL (acetaminophen 500 mg diphenhydramine hydrochloride 25 mg) Dailymed

  1. Human OTC
  2. Archived
    • May Be Discontinued
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  3. GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Generic: acetaminophen and diphenhydramine hcl

PANADOL tablet, film coated - (acetaminophen 500 mg diphenhydramine hydrochloride 25 mg) image

IMPRINT: PANADOL PM     SHAPE: oval
    COLOR: blue

  1. FDA Adverse Reactions

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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 30°C (86°F)

Inactive Ingredients


FD&C blue #1, FD&C blue #2, hypromellose, polyethylene glycol, polysorbate 80, potassium sorbate, povidone, pregelatinized starch, starch, stearic acid, talc, titanium dioxide. Printed with edible ink.

Questions Or Comments?


1-800-981-3511 (English/Spanish) weekdays

Principal Display Panel


NDC 0135-0150-02

PANADOL®

EXTRA STRENGTH

PM

ACETAMINOPHEN

Pain Reliever

DIPHENHYDRAMINE HCl

Nighttime Sleep-Aid

SEE NEW WARNINGS INFORMATION

50 CAPLETS

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

READ AND KEEP CARTON FOR COMPLETE INFORMATION

PANADOL and the Beacon design are registered trademarks of the GSK group of companies.

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GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in Ireland

©2014 GSK group of companies.

All Rights Reserved.

101689XB

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."

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"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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