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PM Get Relief

Eagle Distributors,Inc.

PM Get Relief


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each caplet) Purposes
Acetaminophen 500 mg Pain reliever
Diphenhydramine HCl 25 mg Nighttime sleep aid

PM Get Relief Uses

temporarily relieves 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 product 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

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

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

Adults and children 12 years of age and over Take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
Children under 12 years of age Do not use this adult strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems

PM Get Relief Other information

  • store between20-25 C (68-77 F)
  • do not use if pouch is torn or open

Inactive ingredients

croscarmellose sodium, FD&C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide. May contain polyvinyl alcohol, silicon dioxide, sodium starch glycolate, talc.

Questions or comments?

Call 1-800-570-8650 (M-F 9am to 5pm PST)

Product manufactured for:
Eagle Distributors,Inc.
Los Angeles, CA 90011

PRINCIPAL DISPLAY PANEL - 50 Pouch Carton

See New Warnings Information & Directions
Compare to the Active Ingredients in
Tylenol PM ®*

Extra Strength
PM
Get Relief

Pain Reliever
Nighttime Sleep Air

Acetaminophen, Diphenhydramine HCI

PM Get Relief

PM Get Relief

Acetaminophen and Diphenhydramine Hydrochloride TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68737-224
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
HYPROMELLOSES
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
povidone
STEARIC ACID
titanium dioxide
POLYVINYL ALCOHOL
SILICON DIOXIDE
talc

Product Characteristics

Color Size Imprint Code Shape
BLUE 17 mm AZ;020 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 2 in 1 POUCH
2 NDC:68737-224-08 50 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-06-30


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