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Acetaminophen PM (acetaminophen 500 mg / diphenhydramine hydrochloride 25 mg oral tablet) Dailymed

  1. Human OTC
  2. Histamine-1 Receptor Antagonist
  3. United Natural Foods, Inc. dba UNFI

Generic: acetaminophen, 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

Acetaminophen PM tablet, coated - (acetaminophen 500 mg / diphenhydramine hydrochloride 25 mg oral tablet) image
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IMPRINT: L 6     SHAPE: oval
    COLOR: blue

All Imprints

acetaminophen 500 mg / diphenhydramine hydrochloride 25 mg oral tablet - l 6 oval blue

  1. FDA Adverse Reactions

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Active Ingredients (in Each Gelcap)


Acetaminophen 500 mgDiphenhydramine HCl 25 mg 

Purpose


Pain relieverNighttime 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

  • 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 to this product or any of its ingredients 

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • liver disease
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

Aska doctor or pharmacist before use if you are

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

When using this product

  • drowsiness will occur
  • avoid alcoholic beverages
  • do not drive a motor vehicle or operate 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.
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days

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.


In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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
  • adults and children 12 years and over
    • take 2 gelcaps at bedtime
    • do not take more than 2 gelcaps of this product in 24 hours
  • children under 12 years: do not use 

Other Information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
  • avoid high humidity

Inactive Ingredients


ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide 

Questions Or Comments?


1-855-423-2630

Principal Display Panel


EQUALINE®

compare to Extra Strength Tylenol® PM  active ingredients*

NDC 41163-956-09

extra strength acetaminophen PM gelcapsacetaminophen 500 mgdiphenhydramine HCl 25 mg pain reliever/nighttime sleep aid

20 gelcaps

actual size

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

*This product is not manufactured or distributed byJohnson & Johnson Corporation, owner of theregistered trademark Extra Strength Tylenol® PM.

100 % Quality GUARANTEED

DISTRIBUTED BY UNFIPROVIDENCE, RI 02908 USA 855-423-2630

50844     REV0322H55609
Equaline 44-556

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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