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ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE (acetaminophen 500 mg diphenhydramine hydrochloride 25 mg) Dailymed

  1. Human OTC
  2. Histamine-1 Receptor Antagonist
  3. J.P. BUSINESS ENTERPRISE

Generic: acetaminophen and diphenhydramine hydrochloride 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 AND DIPHENHYDRAMINE HYDROCHLORIDE tablet, film coated - (acetaminophen 500 mg diphenhydramine hydrochloride 25 mg) image
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IMPRINT: S525     SHAPE: oval
    COLOR: blue

All Imprints

acetaminophen 500 mg diphenhydramine hydrochloride 25 mg - s525 oval blue

apap 500 mg / diphenhydramine hydrochloride 25 mg oral tablet - s525 oval blue

  1. FDA Adverse Reactions

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Drug Facts

Otc - Active Ingredient Section


OTC - PURPOSE SECTION

Active ingredients (in each caplet) Purpose
Acetaminophen 500mg Pain reliever
Diphenhydramine HCl 25mg Nighttime Sleep aid

Uses


for the 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 with this product if you take
  • more than 2 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while you are using this product

Do not use

  • with other products containing acetaminophen (prescription or nonprescription).

If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • in children under 12 years of age
  • with any other products containing diphenhydramine, even one used on skin
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have

  • liver cirrhosis
  • asthma
  • breathing problems such as emphysema or chronic bronchitis
  • trouble in urinating due to an 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 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 a serious underlying medical illness
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION


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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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 right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

adults and children 12 years of age and over:
  • take 2 caplets at bedtime or as directed by a doctor
  • do not take more than 2 caplets in a 24 hour period
children under 12 years or age:
  • do not use this adult product in children under 12 years of age. This will provide more than the recommended dose (overdose) and may cause liver damage

Other Information

  • store at 20°-25°C (68°-77°F)
  • see end panel for lot number and expiration
  • each tablet contains: magnesium 0.05 mg

Inactive Ingredients


FD&C blue # 1, FD&C blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol-400, pregelatinized starch, povidone, stearic acid, titanium dioxide

Questions Or Comments?


1-888-333-9792


Distributed By: J.P Business Enterprise Lake Grove, NY 11755

Principal Display Panel - 24 Caplet Bottle Carton


VALUMEDS

SEE NEW WARNINGS INFORMATION

Compare to the active ingredients in TYLENOL ® PM *

EXTRA STRENGTH

PAIN RELIEF PM

PAIN RELIEVER • NIGHTTIME SLEEP AID

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

24 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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