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healthy mama (acetaminophen 500 mg diphenhydramine hydrochloride 25 mg) Dailymed

  1. Human OTC
  2. Histamine-1 Receptor Antagonist
  3. MATERNAL SCIENCE, LLC

Generic: acetaminophen 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

healthy mama tablet, film coated - (acetaminophen 500 mg diphenhydramine hydrochloride 25 mg) image

IMPRINT: GP325     SHAPE: oval
    COLOR: white

  1. FDA Adverse Reactions

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Active Ingredient (in Each Caplet)


Acetaminophen 500 mg

Diphenhydramine HCl 25mg

Purposes


Pain RelieverNighttime Sleep Aid

Uses


Temporary relief of occasional headaches and minor aches with 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 everyday while using this product

When using this prodcut

  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


Keep out of reach of children.

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.
  • In children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If You Are

  • 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

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 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.

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

  • 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 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 room temperature

Inactive Ingredients


Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.

Questions?


If you have any questions or comments. or to report  an adverse event, please contact (xxx) xxx-xxxx.

Principal Display Panel


healthy

mama

eaZZZe THE PAIN!

acetaminophen 500mg diphenhydramine HCl 25 mg

PAIN RELIEVER AND NIGHTTIME AID

extra strength aspirin free

40 caplets



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"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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