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Headache PM (acetaminophen 500 mg diphenhydramine citrate 38 mg) Dailymed

  1. Human OTC
  2. Archived
    • May Be Discontinued
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  3. GREENBRIER INTERNATIONAL, INC.

Generic: acetaminophen and diphenhydramine citrate

Headache PM tablet, film coated - (acetaminophen 500 mg diphenhydramine citrate 38 mg) image
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IMPRINT: 44 373     SHAPE: round
    COLOR: blue

All Imprints

acetaminophen 500 mg / diphenhydramine citrate 38 mg oral tablet - 44 373 round blue

  1. FDA Adverse Reactions

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Active Ingredients (in Each Tablet)


Acetaminophen 500 mgDiphenhydramine citrate 38 mg

Purpose


Pain relieverNighttime 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 if you take:

  • more than 2 tablets in 24 hours, which is the maximum daily amount

  • with other drugs containing acetaminophen

  • 3 or more alcoholic drinks every day while using this product

Do not use

  • if you are allergic to acetaminophen
  • 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

Ask a doctor before use if you have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland 
  • glaucoma

Ask a doctor or pharmacist before use if you are

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

When using this product


  • drowsiness may occur

  • avoid alcoholic beverages

  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if


  • sleeplessness lasts 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

  • painful area is red or swollen

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 (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 tablets at bedtime, if needed, or as directed by a doctor
  • children under 12 years: do not use 

Other Information


  • store at 25ÂşC (77ÂşF); excursions permitted between 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

Inactive Ingredients


corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, shellac, silica gel, stearic acid, titanium dioxide

Questions Or Comments?


1-800-426-9391

Principal Display Panel


ASSURED™

*COMPARE TO  ACTIVE INGREDIENTS OF EXCEDRIN® PM*

ASPIRIN FREE Headache PM• Acetaminophen 500 mg  Pain Reliever • Diphenhydramine Citrate 38 mg   Nighttime Sleep-Aid

Actual SizeNON HABIT FORMING 20 tablets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excedrin® PM.50844    REV0414B37309

ITEM# 194143

DISTRIBUTED BYGREENBRIER INTERNATIONAL, INC.500 VOLVO PARKWAY CHESAPEAKE, VA 23320

Assured 44-373

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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