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

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Extra Strength Pain Reliever PM

Safeway

Safeway 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
  • in children under 12 years of age
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product 
  • a breathing problem such as emphysema or chronic bronchitis
  • liver disease
  • glaucoma
  • 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
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • 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
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid high humidity
  • 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

1-800-426-9391

Principal Display Panel

NDC 21130-556-31
Compare to Extra Strength Tylenol® PM active ingredients*

Extra Strength
Pain Reliever PM
Acetaminophen
, 500 mg
Diphenhydramine HCl, 25 mg
• Pain Reliever/Nighttime Sleep Aid
• Rapid Release Gels

80 GELCAPS

SAFEWAY®

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributors of Extra Strength Tylenol® PM .

50844        REV0413C55631

DISTRIBUTED BY SAFEWAY INC., P.O. BOX 99
PLEASANTON, CA 94566-0009
QUALITY & SATISFACTION GUARANTEED OR
YOUR MONEY BACK
1-888-SAFEWAY / www.safeway.com

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

Extra Strength Pain Reliever PM

Safeway 44-556-31

Extra Strength Pain Reliever PM

Acetaminophen and Diphenhydramine HCl CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:21130-556
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
HYDROXYPROPYL CELLULOSE (TYPE H)
HYPROMELLOSES
POLYETHYLENE GLYCOLS
propylene glycol
STEARIC ACID
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
BLUE 21 mm L;6 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 80 in 1 BOTTLE, PLASTIC
2 NDC:21130-556-31 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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