Aspirin Free Headache PM description, usages, side effects, indications, overdosage, supplying and lots more!

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Aspirin Free Headache PM

Greenbrier International, Inc.

Assured 44-373


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each tablet)

Acetaminophen 500 mg
Diphenhydramine citrate 38 mg

Purpose

Pain reliever
Nighttime sleep-aid

Aspirin Free Headache PM 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 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 (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

  • 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.

Aspirin Free Headache PM Other information

  • store at 25ºC (77ºF); excursions permitted between 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 or comments?

1-800-426-9391

Principal Display Panel

ASSURED™

*COMPARE TO THE ACTIVE INGREDIENT IN EXCEDRIN® PM

Aspirin Free
HEADACHE PM
• Acetaminophen
500 mg - Pain Reliever
• Diphenhydramine citrate 38 mg - Nighttime Sleep-Aid

NON-HABIT FORMING
40 tablets

*This product is not manufactured or distributed by Novartis Consumer Health, owner of the registered trademark Excedrin® PM.
50844    ORG071237310

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

Aspirin Free Headache PM
Assured 44-373

Aspirin Free Headache PM

Acetaminophen and Diphenhydramine Citrate TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:33992-0373
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE 38 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
CROSPOVIDONE
FD&C BLUE NO. 1
FD&C BLUE NO. 2
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
polysorbate 80
POVIDONES
STEARIC ACID
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
BLUE 11 mm 44;373 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 40 in 1 BOTTLE, PLASTIC
2 24 in 1 BOTTLE, PLASTIC
3 20 in 1 BOTTLE, PLASTIC
4 NDC:33992-0373-9 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2004-06-07


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Be sure to consult your doctor before taking any medication!
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