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

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Pain Relief PM

Topco Associates LLC (Top Care)

DRUG FACTS


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

Pain Relief PM Uses

Temporary relief of occasional headaches and minor aches and pains accompanying sleeplessness

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 2 caplets in 24 hours, which is maximum daily amount 
  • 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 other products containing diphenhydramine, even one used on skin
  • in children under 12 years of age
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • 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 drinks
  • 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 serious underlying medical illness.
  • pain gets worse or lasts more than 10 days 
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

If pregnant or breast-feeding,

ask a health care 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 (1-800-222-1222). 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

Other information

  • store at room temperature 15o- 30o C (59o- 86o F), avoid high humidity and excessive heat

Inactive ingredients

colloidal silicon dioxide*, croscarmellose sodium*, D&C Yellow #10 Aluminum Lake*, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, hypromellose, magnesium silicate*, magnesium stearate*, microcrystalline cellulose, mineral oil*, polyethylene glycol, polyvinyl alcohol*, povidone, pregelatinized starch, silica*, sodium starch glycolate*, stearic acid, talc*, titanium dioxide, triacetin*, and yellow iron oxide*

*contains one or more of these ingredients

Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

Compare to TYLENOL® PM active ingredients**

extra strength

Non Habit forming

Pain Relief PM

ACETAMINOPHEN 500 mg

DIPHENHYDRAMINE HCl 25 mg

Pain reliever/ Nighttime Sleep Aid

**This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® PM

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

Product Label

Pain Relief PM

Pain Relief PM Caplets
 

Pain Relief PM

Acetaminophen, Diphenhydramine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:36800-438
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
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
HYPROMELLOSES
magnesium silicate
MAGNESIUM STEARATE
cellulose, microcrystalline
Mineral Oil
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
POVIDONES
STARCH, CORN
SILICON DIOXIDE
sodium starch glycolate type a corn
STEARIC ACID
titanium dioxide
triacetin
FERRIC OXIDE YELLOW
talc
ALUMINUM OXIDE

Product Characteristics

Color Size Imprint Code Shape
BLUE 18 mm S525;V15;AV;CPC;752 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 50 in 1 BOTTLE
2 NDC:36800-438-71 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 2011-12-08


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Be sure to consult your doctor before taking any medication!
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