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

  1. Human OTC
  2. Archived
  3. Allegiant Health

Generic: acetaminophen 500 mg and diphenhydramine hcl 25 mg

Sound Body Pain Relief PM tablet, coated - (acetaminophen 500 mg diphenhydramine hydrochloride 25 mg) image
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IMPRINT: AZ267     SHAPE: oval
    COLOR: blue

All Imprints

acetaminophen 500 mg / diphenhydramine hydrochloride 25 mg oral tablet - az267 oval blue

  1. FDA Adverse Reactions

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Active Ingredients (in Each Caplet)


Acetaminophen 500mgDiphenhydramine HCl 25mg

Purposes


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 4000 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 have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you

  • 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 will occur
  • avoid alcoholic drinks
  • 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 serious underlying medical illness.
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

These could be signs of a serious condition.
  • You may report side effects to 1-888-952-0050

If pregnant or breast-feeding,


If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children


Keep out of reach of children. Overdose warning: 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 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
  • children under 12 years: do not use

Other Information

  • store between 20-25°C (68-77° F)
  • do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients


croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glylcol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

Principal Display Panel


SOUNDBODYâ„¢

Compare to the Active Ingredients in Extra Strength Tylenol® PM*

See New Warnings Information

Pain Relief PMAcetaminophen 500 mg/Diphenhydramine 25 mg

Pain Reliever, Nighttime Sleep Aid

100 Caplets

(pill image) actual size

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

LB1303R0617

Distributed by: Allegiant Health Deer Park, NY 11729

V#5003620     ITEM#FP0641
Pain Relief PM 100ct. Caplets Pain Relief PM 100ct. Caplets

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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