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Dosage form: tablet
Ingredients: Acetaminophen 500mg, Diphenhydramine Hydrochloride 25mg
Labeler: Eagle Distributors,Inc.
NDC Code: 68737-224

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients (in each caplet)Purposes
Acetaminophen 500 mgPain reliever
Diphenhydramine HCl 25 mgNighttime sleep aid

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

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

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Compare to the Active Ingredients in
Tylenol PM®*

Extra Strength
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Pain Reliever
Nighttime Sleep Air

Acetaminophen, Diphenhydramine HCI

PM GET RELIEF 
acetaminophen and diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68737-224
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen500 mg
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride25 mg
Inactive Ingredients
Ingredient NameStrength
croscarmellose sodium 
FD&C blue no. 1 
hypromelloses 
cellulose, microcrystalline 
polyethylene glycols 
povidone 
stearic acid 
titanium dioxide 
polyvinyl alcohol 
silicon dioxide 
talc 
Product Characteristics
ColorBLUEScore2 pieces
ShapeOVAL (Capsule shape) Size17mm
FlavorImprint CodeAZ;020
Contains    
Packaging
#Item CodePackage Description
1NDC:68737-224-0850 POUCH in 1 BOX
12 TABLET in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/30/2012
Labeler - Eagle Distributors,Inc. (929837425)

Revised: 06/2012
 
Eagle Distributors,Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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