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

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Acetaminophen PM

Rite Aid

Rite Aid 44-556


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient(s)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever

Nighttime sleep-aid

Use(s)

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

Ask a doctor before use if

  • liver disease
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland 

Ask a doctor or pharmacist before use if

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • drowsiness will occur
  • aboid alcoholic beverages
  • do not drive a motor vehicle or operate machiner 

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

Acetaminophen PM Other information

  • store at controlled room temperature 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

 colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinied starch, propylene gllycol, shellac glaze, stearic acid, titanium dioxide

Questions

 1-800-426-9391

Principal Display Panel

RITE

AID®

PHARMACY

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

EXTRA STRENGTH

pain relief

acetaminophen PM

acetaminophen 500 mg

diphenhydramine HCl 25 mg

pain reliever • nighttime sleep aid

non-habit forming

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

50844      ORG021055631

DISTRIBUTED BY: RITE AID

30 HUNTER LANE

CAMP HILL, PA 17011

Acetaminophen PM

Acetaminophen PM

Acetaminophen and Diphenhydramine HCl CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11822-0556
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
FD&C RED NO. 3
hydroxypropyl cellulose
HYPROMELLOSES
polyethylene glycol
povidone
propylene glycol
STEARIC ACID
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
BLUE (grey and light blue) 21 mm 44;556 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 80 in 1 BOTTLE, PLASTIC
2 100 in 1 BOTTLE, PLASTIC
3 20 in 1 BOTTLE, PLASTIC
4 NDC:11822-0556-9 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2007-12-17


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Be sure to consult your doctor before taking any medication!
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