Extra Strength Pain Reliever PM description, usages, side effects, indications, overdosage, supplying and lots more!

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Extra Strength Pain Reliever PM

L.N.K. International, Inc.

Quality Plus 44-235


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever Nighttime

sleep-aid

Extra Strength Pain Reliever PM Uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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

  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

  • 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 you are

  • taking the blood thinning drug warfarin

  • taking sedatives or tranquilizers

When using this product

  • drowsiness will occur

  • avoid alcoholic beverages

  • do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

  • new symptoms occur

  • redness or swelling is present

  • pain gets worse or lasts more than 10 days

  • fever gets worse or lasts more than 3 days

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 caplets at bedtime. Do not take more than 2 caplets 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.

Extra Strength Pain Reliever 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

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue #1, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

QUALITY PLUS

See New Warnings Information

*Compare to the active ingredients in Extra Strength TYLENOL®PM

NDC 50844-235-15

EXTRA STRENGTH

Pain Reliever PM

Acetaminophen 500 mg • Diphenhydramine HCl 25 mg

PAIN RELIEVER / NIGHTTIME SLEEP-AID

50 Caplets

NON-ASPIRIN

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

50844    REV0410E23515

Distributed by LNK Internaitional, Inc.

60 Arkay Drive, Hauppauge, NY 11788

Extra Strength Pain Reliever PM

Extra Strength Pain Reliever PM

Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50844-235
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg

Inactive Ingredients

Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 1
cellulose, microcrystalline
polyethylene glycol
POLYVINYL ALCOHOL
povidone
STEARIC ACID
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
BLUE 17 mm 44;235 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 50 in 1 BOTTLE, PLASTIC
2 NDC:50844-235-15 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 1994-05-15


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Be sure to consult your doctor before taking any medication!
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