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

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Extra Strength Acetaminophen PM

McKesson

Extra Strength Acetaminophen PM


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each geltab)

Acetaminophen 500mg

Diphenhydramine HCl 25mg

Purpose

Pain Reliver

Nighttime sleep aid

Extra Strength Acetaminophen PM Uses

for temporary relief of occasional headaches, minor aches and pains accompanying sleeplessness.

Warnings

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

  • more than 2 geltabs in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Overdose warning:Taking more than the recommended dose (overdose) may cause liver damage.

Ask a doctor before use if you have


  • liver disease
  • asthma
  • breathing problems such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urinating due to an enlargement of the prostate gland

Do not use

  • with other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • in children under 12 years of age
  • with other products containing diphenhydramine, even one used on skin
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if you are

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

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

  • new symptoms occur
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • redness or swelling is present
  • sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

If pregnant or breast-feeding,

ask a health care professional before use.


Directions

  • do not exceed recommended dose
  • adults and children 12 years of age and over: take 2 geltabs at bedtime. Do not take more than 2 geltabs in 24 hours
  • children under 12 years of age: 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 15°-30°C (59°-86°F), avoid high humidity and excessive heat
  • do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

corn starch, DandC Red #27 aluminum lake, edible black ink, FDandC Blue #1 aluminum lake, gelatin, glycerin, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, purified water, silicon dioxide, sodium starch glycolate, stearic acid and titanium dioxide.

Questions or comments?

call toll free: 1-877-753-3935

















Product Package Label

Extra Strength Acetaminophen PM

Product Carton Label

Extra Strength Acetaminophen PM

Extra Strength Acetaminophen PM

ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:62011-0024
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
STARCH, CORN
D&C RED NO. 27
ALUMINUM OXIDE
FD&C BLUE NO. 1
GELATIN
GLYCERIN
HYPROMELLOSES
maltodextrin
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
povidone
water
SILICON DIOXIDE
STEARIC ACID
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
white (WHITE) 13 mm BP50 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 50 in 1 BOTTLE
2 NDC:62011-0024-1 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2012-04-09


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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