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Pain Relief PM (acetaminophen 500 mg diphenhydramine hydrochloride 25 mg) Dailymed

  1. Human OTC
  2. Archived
  3. SUPERVALU INC.

Generic: acetaminophen and diphenhydramine hcl

Pain Relief PM tablet - (acetaminophen 500 mg diphenhydramine hydrochloride 25 mg) image

IMPRINT: 44 235     SHAPE: oval
    COLOR: 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

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
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
  • in children under 12 years of age

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

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

When using this product

  • avoid alcoholic beverages
  • drowsiness will occur
  • 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.


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 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 25ÂşC (77ÂşF); excursions permitted between 15Âş-30ÂşC (59Âş-86ÂşF)
  • 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?


1-877-932-7948

Principal Display Panel


EQUALINE®

compare toExtra Strength Tylenol® PM active ingredients*

NDC 41163-556-09

extra strengthacetaminophen PM gelcapsacetaminophen 500mgdiphenhydramine HCl 25mg

• pain reliever/nighttime sleep aid• non-habit forming• rapid release

20 gelcaps

actual size

DOES NOT CONTAIN GLUTEN

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® PM.

50844        REV0413D55609

DISTRIBUTED BY SUPERVALU INC.EDEN PRAIRIE, MN 55344 USA

Contact us at 1-877-932-7948, or www.supervalu-ourownbrands.com

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

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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