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Headache Relief PM Dailymed

  1. Human OTC
  2. Archived
    • May Be Discontinued
      Try Other Labelers
  3. CHAIN DRUG MARKETING ASSOCIATION INC

Generic: acetaminophen and diphenhydramine citrate

Headache Relief PM tablet - image

  1. FDA Adverse Reactions

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Active Ingredient(s)


Acetaminophen 500 mg

Diphenhydramine citrate 38 mg

Purpose


Pain reliever

Nighttime sleep-aid

Use(s)


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 containin diphenhydramine, even one used on skin

  • in children under 12 years of age

Ask a doctor before use if


  • a breathing problem such as emphysema or chronic bronchitis

  • liver disease

  • trouble urinating due to an enlarged prostate gland

  • glaucoma

Ask a doctor or pharmacist before use if


  • taking sedatives or tranquilizers

  • taking the blood thinning drug warfarin

When using this product


  • drowsiness may occur

  • avoid alcoholic beverages

  • be careful when driving a motor vehicle or operating machinery

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.

  • pain gets worse or lasts more than 10 days

  • fever gets worse or lasts more than 3 days

  • new symptoms occur

  • 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 controlled room temperature 15°-30°C (59°-86°F)

  • 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


1-800-426-9391

Principal Display Panel


The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

QC

QUALITY

CHOICE®

NDC 63868-159-01

Compare to the active ingredients

in Excedrin® PM*

See New Warnings Information

HEADACHE RELIEF PM

Acetaminophen 500 mg,

Diphenhydramine citrate 38 mg

Pain Reliever / Nighttime Sleep-Aid

Aspirin Free

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

50844     ORG031037312

© DISTRIBUTED BY QUALITY CHOICE

NOVI, MI 48376-0995

QC 96596
Product Packaging

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