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

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Headache Relief PM

VALUE MERCHANDISERS COMPANY, INC.

Best Choice 44-373


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

Headache Relief PM 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.

Best Choice® Brand

HEALTH CARE

*COMPARE TO ACTIVE INGREDIENTS

OF EXCEDRIN® PM

SEE NEW WARNINGS INFORMATION

Aspirin-Free

HEADACHE RELIEF PM

Acetaminophen 500 mg, Diphenhydramine Citrate 38 mg

PAIN RELIEVER / NIGHTTIME SLEEP AID

50 TABLETS

Non-Habit Forming

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

50844     ORG031037315

PROUDLY DISTRIBUTED BY:

VALU MERCHANDISERS, CO.

KANSAS CITY, MO. 64111

Headache Relief PM
Product Packing

Headache Relief PM

Acetaminophen and Diphenhydramine Citrate TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63941-373
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 glycol
polysorbate 80
povidone
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 50 in 1 BOTTLE, PLASTIC
2 NDC:63941-373-15 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 2004-06-07


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Be sure to consult your doctor before taking any medication!
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