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Acetaminophen Diphenhydramine HCl (acetaminophen 500 mg diphenhydramine hydrochloride 25 mg) Dailymed


Generic: acetaminophen diphenhydramine hcl 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

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Active Ingredients


(in each gelcap)

Acetaminophen, USP 500 mg

Diphenhydramine HCl 25 mg

Purposes


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

â–  more than 4,000 mg of acetaminophen in 24 hours

â–  with other drugs containing acetaminophen

â–  3 or more alcoholic drinks every day while using this product

Allergy Alert


acetaminophen may cause severe skin reaction. Symptoms may include:

â–  skin reddening

â–  bulers

â–  rash

If a skin reaction occurs, stop use and seek medical help right away.

Do Not Use


â–  with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

â–  with any other product containing diphenhydramine, even one used on skin

â–  in children under 12 years of age

â–  if you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If You Have


â–  liver disease

â–  glaucoma

â–  a breathing problem such as emphysema or chronic bronchitis

â–  trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are


â–  taking the blood thinning drug warfarin

â–  taking sedatives or tranquilizers

When Using This Product


â–  drowsiness will occur

â–  avoid alcoholic drinks

â–  do not drive a motor vehicle or operate machinery

Stop Use And Ask A Doctor If


â–  sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

â–  pain gets worse or lasts more than 10 days

â–  fever gets worse or lasts more than 3 days

â–  new symptoms occur

â–  redness or swelling is present

These could be signs of a serious condition.

If Pregnant Or Breast-feeding


ask a health professional before use.

Keep Out Of The 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


â–  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 between 20°-25°C (68°-77°F). See USP Controlled Room Temperature.

â–  see end panel for expiration date and lot number.

Inactive Ingredients


colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2, FD&C red #40, FD&C Yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, n-butyl alcohol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, triacetin.

Questions Or Comments?


call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

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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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