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

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Pain Relief PM

WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

CVS 44-556


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Acetaminophen 500 mg
Diphenhydramine HCl 25 mg

Pain reliever
Nighttime sleep-aid

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
  • 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
  • liver disease
  • glaucoma
  • a breathing problem such as emphysema or chronis bronchitis
  • trouble urinating due to an enlarged prostate gland
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
  • drowsiness will occur
  • avoid alcoholic beverages
  • do not drive a motor vehicle or operate machinery
  • 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.

ask a health professional before use.

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.

  • 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.
  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

ammonium hydroxide, 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, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide

Product Packaging

CVS
pharmacy™

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

Extra Strength
PAIN RELIEF PM
RAPID RELEASE GELCAPS
ACETAMINOPHEN, DIPHENHYDRAMINE HCl
Pain Reliever / Nighttime Sleep Aid

40 GELCAPS

FAST RELEASE

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength TYLENOL®.
50844          REV0712C55609

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2013 CVS/pharmacy
www.cvs.com              1-800-shop-CVS
V-11112

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

Pain Relief PM
CVS 44-556

Pain Relief PM

Acetaminophen, Diphenhydramin HCl CAPSULE, GELATIN COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-556
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 1
FD&C RED NO. 3
GELATIN
HYDROXYPROPYL CELLULOSE (TYPE H)
HYPROMELLOSES
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
POVIDONES
propylene glycol
STEARIC ACID
titanium dioxide

Product Characteristics

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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BOTTLE, PLASTIC
2 40 in 1 BOTTLE, PLASTIC
3 80 in 1 BOTTLE, PLASTIC
4 NDC:59779-556-76 450 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2007-12-17


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Be sure to consult your doctor before taking any medication!
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