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pain reliever pm

McKesson (Sunmark)
P and L Development of New York Corporation

Extra Strength Acetaminophen PM


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DRUG FACTS

Active ingredients (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever

Nighttime sleep- aid

pain reliever pm Uses

temporary 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

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 a serious underlying medical illness.
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for 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: 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

pain reliever pm Other information

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

Inactive ingredients

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

*contains one or more of these ingredients

Questions or Comments?

Call 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Principal Display Panel

Compare to EXTRA STRENTH Tylenol® PM active ingredients **

Pain Reliever PM

Extra Strength

Pain reliever /nighttime Sleep-Aid

Non- habit forming

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

pain reliever pm
Pain Reliever PM caplets

pain reliever pm

Acetaminophen, Diphenhydramine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49348-236
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
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 1
FD&C BLUE NO. 2
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
POVIDONES
STEARIC ACID
titanium dioxide
D&C YELLOW NO. 10
magnesium silicate
Mineral Oil
STARCH, CORN
SILICON DIOXIDE
sodium starch glycolate type a corn
triacetin

Product Characteristics

Color Size Imprint Code Shape
BLUE 18 mm S525;CPC752 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BOTTLE
2 NDC:49348-236-10 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2013-03-26


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Be sure to consult your doctor before taking any medication!
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