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Acetaminophen and Diphenhydramine HCl (diphenhydramine hydrochloride 12.5 mg acetaminophen 325 mg) Dailymed


Generic: acetagesic


IMPRINT: AP 126     SHAPE: round
    COLOR: orange

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Active Ingredient


Acetaminophen 325 mg and Diphenhydramine HCl 12.5 mg

Purposes


Pain Reliever/Fever ReducerAntihistamine

Uses


Temporarily reduces fever and relieves minor aches and pain caused by
  • •common cold
  • •headache
  • •toothache
  • •muscular aches
  • •backache
  • •arthritis
  • •flu
  • •premenstrual and menstrual cramps

Warnings


Liver warning: This product contains acetaminophen. Severe liver damage may occur if
  • •adult or child 12 years and older takes more than 8 tablets in less than 24 hours which is the maximum daily amount
  • •taken with other drugs containing acetaminophen
  • •adult has 3 or more alcoholic drinks everyday while using this product.
  •   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 drug containing diphenhydramine, even one used on skin
  •   Ask a doctor before use if the user has
  • •liver disease
  • •glaucoma
  • •a breathing problem such as emphysema or chronic bronchitis
  • •trouble urinating due to an enlarged prostate gland
  •   Ask a doctor or pharmacist before use if the user is.
  • •taking the blood thinning drug warfarin
  • •taking sedatives or tranquilizers
  •   When using this product
  • •you may get very drowsy
  • •avoid alcoholic drinks
  • •alcohol, sedatives and tranquilizers may increase drowsiness
  • •be careful when driving a motor vehicle or operating machinery
  • •excitability may occur, especially in children
  •   Stop use and ask a doctor if
  • •pain gets worse or lasts more than 10 days
  • •fever gets worse or lasts more than 3 days
  • •redness or swelling is present
  • •any new symptoms appear
  •   If pregnant or breast feeding, ask a health professional before use.
  •   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). Prompt 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 & over: take 2 tablets every 4 hours, but not more than 8 tablets in 24 hours
  • • children under 12 years: do not use

Other Information


Store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients


colloidal silicon dioxide, croscarmellose sodium, FD&C yellow #6 (al-lake), hypromellose, microcrystalline cellulose, mineral oil, polyethylene glycol, povidone, pregelatinized starch, purified water, stearic acid, titanium dioxide.

Questions


Call 1-800-645-2158, 9 am – 5 pm ET, Monday – Friday.

Package Label.principal Display Panel

  • • TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

100 Tablets

NDC 0536-3605-01

Rugby

Acetaminophen 325 mg / Diphenhydramine HCl 12.5 mg

Pain Reliever, Fever Reducer, Antihistamine

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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