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

  1. Human OTC
  2. Archived
  3. Family Dollar Services Inc

Generic: acetaminophen and diphenhydramine hcl

Acetaminophen PM tablet - (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

  • 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
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the 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 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid high humidity
  • see end flap for expiration date and lot number

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?


1-800-426-9391

Principal Display Panel


FAMILYwellness™

COMPARE TO THE ACTIVE INGREDIENTS OFEXTRA STRENGTH TYLENOL® PM* 

EXTRA STRENGTH Acetaminophen PM Acetaminophen 500 mgDiphenhydramine HCl 25 mg

Pain Reliever, Nighttime Sleep-Aid

Non-Habit Forming

40 RAPID RELEASE GELCAPS

ACTUAL SIZE

OTC network

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

DISTRIBUTED BY: MIDWOOD BRANDS, LLC 10611 MONROE RD.MATTHEWS, NC 28105

NOT 100% SATISFIED? Return package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange.

*This product is not manufactured ordistributed by Johnson & JohnsonCorporation, owner of the registeredtrademark Extra Strength Tylenol® PM.50844      REV0417E55610
Family Wellness 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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