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Headache Formula PM (acetaminophen 500 mg diphenhydramine citrate 38 mg) Dailymed

  1. Human OTC
  2. Archived
    • May Be Discontinued
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  3. SUPERVALU INC.

Generic: acetaminophen and diphenhydramine citrate

Headache Formula PM tablet, film coated - (acetaminophen 500 mg diphenhydramine citrate 38 mg) image
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IMPRINT: 44 373     SHAPE: round
    COLOR: blue

All Imprints

acetaminophen 500 mg / diphenhydramine citrate 38 mg oral tablet - 44 373 round blue

  1. FDA Adverse Reactions

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Active Ingredients (in Each Tablet)


Acetaminophen 500 mgDiphenhydramine citrate 38 mg

Purpose


Pain relieverNighttime 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 if you take:
  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day 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 product containing diphenhydramine, even one used on skin
  • 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
  • trouble urinating due to an enlarged 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

  • avoid alcoholic beverages
  • be careful when driving a motor vehicle or operating machinery
  • drowsiness may occur 

Stop use and ask a doctor if

  • sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • new symptoms occur
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • painful area is red or swollen

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.


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. 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 tablets at bedtime. Do not take more than 2 tablets 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number  

Inactive Ingredients


corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, shellac, silica gel, stearic acid, titanium dioxide

Questions Or Comments?


1-877-932-7948

Principal Display Panel


equaline®

compare to Excedrin® PM active ingredients*

NDC 41163-373-12

headache formula PM

acetaminophen and diphenhydramine citrate

aspirin freepain reliever / nighttime sleep-aid

100 tablets

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

DOES NOT CONTAIN GLUTEN

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excedrin® PM.50844     REV0712A37312

DISTRIBUTED BY SUPERVALU INC. EDEN PRAIRIE, MN 55344 USA

Contact us at 1-877-932-7948, or www.supervalu-ourownbrands.com
Equaline 44-373

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."

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"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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