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Acetaminophen and Diphenhydramine hydrochloride Dailymed

  1. Human OTC
    • Drug Classes
  3. Aurohealth LLC

Generic: acetaminophen and diphenhydramine hydrochloride

Acetaminophen and Diphenhydramine hydrochloride tablet - image

  1. FDA Adverse Reactions

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Drug Facts


Active ingredients (in each gelcap) Acetaminophen USP 500 mg Diphenhydramine hydrochloride USP 25 mg

Purpose


Pain reliever Nighttime 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
  • with other drugs containing acetaminophen
  • more than 4,000 mg of acetaminophen in 24 hours
  • 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
  • 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

  • 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

  • pain gets worse or lasts more than 10 days
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
  • new symptoms occur
  • redness or swelling is present
  • 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

  • avoid high humidity
  • store at 20º to 25°C (68º to 77°F)
  • use by expiration date on package

Inactive Ingredients


ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch (maize), propylene glycol, shellac glaze, talc, and titanium dioxide.

Questions Or Comments?


1-855-274-4122 Distributed by: AUROHEALTH LLC 279 Princeton- Hightstown Road, East Windsor, NJ 08520 Made in India Code: TS/DRUGS/16/2014

Package Label-principal Display Panel 500 Mg/25 Mg (20 Gelcaps Bottle)


AUROHEALTH NDC 58602-760-73 EXTRA STRENGTH Acetaminophen and Diphenhydramine Hydrochloride Gelcaps 500 mg/25 mg Pain Reliever, Nighttime Sleep Aid Non-Habit Forming Rapid Release 20 GELCAPS

Package Label-principal Display Panel 500 Mg/25 Mg (20 Gelcaps Bottle Carton)


AUROHEALTH Compare to the active ingredients in Extra Strength Tylenol ®PM NDC 58602-760-73 EXTRA STRENGTH Acetaminophen and Diphenhydramine Hydrochloride Gelcaps 500 mg/25 mg Pain Reliever, Nighttime sleep aid Non-habit forming Rapid Release   20 GELCAPS

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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