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

  1. Human OTC
  2. Archived
    • May Be Discontinued
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  3. DOLGENCORP, LLC

Generic: acetaminophen and diphenhydramine citrate

Headache Relief PM tablet - (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 Ingredient(s)


Acetaminophen 500 mg

Diphenhydramine citrate 38 mg

Purpose


Pain reliever

Nighttime sleep-aid

Use(s)


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 4,000 mg of acetaminophen in 24 hours

  • with other drugs containing acetaminophen

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

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 containin diphenhydramine, even one used on skin

  • in children under 12 years of age

Ask a doctor before use if


  • a breathing problem such as emphysema or chronic bronchitis

  • liver disease

  • trouble urinating due to an enlarged prostate gland

  • glaucoma

Ask a doctor or pharmacist before use if


  • taking sedatives or tranquilizers

  • taking the blood thinning drug warfarin

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 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 and over: take 2 tablets at bedtime. Do not take more than 2 tablets of this product in 24 hours.

  • children under 12 years: 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.

Other Information


  • store at controlled room temperature 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


1-800-426-9391

Principal Display Panel


The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

DG™

health

Compare to active ingredients in Excedrin® PM*

Headache Relief PM

SEE NEW WARNINGS INFORMATION

Aceetaminophen 500 mg • Diphenhydramine citrate 38 mg

Pain Reliever/Nighttime Sleep-Aid

•Aspirin Free

50 Tablets

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

50844    ORG031037315

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072
Product Packaging

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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