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Extra Strength Acetaminophen PM

Medically reviewed on January 25, 2017

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Cardinal Health
NDC Code: 70000-0149

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.

Extra Strength Acetaminophen PM Caplets

Drug Facts


Active ingredients (in each caplet)

Acetaminophen 500 mg
Diphenhydramine HCl 25 mg

Purposes

Pain Reliever
Nighttime Sleep Aid

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

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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.

  • in children under 12 years of age

  • with any other product containing diphenhydramine, even one used on skin

  • 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

  • difficulty in urination due to enlargement of the 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.

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur

  • redness or swelling is present

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

‚ÄčOther information

  • store at room temperature

Inactive ingredients Croscarmellose sodium, crospovidone, FD&C blue #1, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, silica, sodium starch glycolate, stearic acid, titanium dioxide

Questions or Comments?

call ( 800) 795-9775

Do not use if carton is open, or if imprinted safety seal under cap is broken or missing.

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OH 43017

CIN 4760310

www.myleader.com 1-800-200-6313

NDC 70000-0149-1

LEADER™

Extra Strength

Acetaminophen PM

Acetaminophen 500 mg, Diphenhydramine HCl, 25 mg Caplets

Pain Reliever | Sleep Aid

Non-Habit Forming

24 CAPLETS

EXTRA STRENGTH ACETAMINOPHEN PM 
acetaminophen and diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0149
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
HYDROXYPROPYL CELLULOSE, UNSPECIFIED 
STARCH, PREGELATINIZED CORN 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 1 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
POVIDONES 
STEARIC ACID 
TITANIUM DIOXIDE 
CROSPOVIDONE 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
PROPYLENE GLYCOL 
Product Characteristics
ColorblueScoreno score
ShapeOVALSize18mm
FlavorImprint CodeGP325
Contains    
Packaging
#Item CodePackage Description
1NDC:70000-0149-11 BOTTLE, PLASTIC in 1 CARTON
124 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2NDC:70000-0149-31 BOTTLE, PLASTIC in 1 CARTON
2100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
3NDC:70000-0149-21 BOTTLE, PLASTIC in 1 CARTON
350 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/22/2016
Labeler - Cardinal Health (097537435)

 
Cardinal Health

← See all Extra Strength Acetaminophen PM brands

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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