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Legatrin PM

Medically reviewed on September 8, 2017.

Dosage form: tablet
Ingredients: ACETAMINOPHEN 5001, DIPHENHYDRAMINE HYDROCHLORIDE 501
Labeler: Church & Dwight Co., Inc.
NDC Code: 10237-907

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.

Legatrin PM Pain Reliever/Sleep Aid

Active ingredients (in each caplet)

Active ingredients (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCI 50 mg

Purposes

Purposes

Acetaminophen - Pain Reliever

Diphenhydramine HCI - Sleep Aid

Uses

Uses

temporary relief of minor aches and pains, such as leg cramp pain, joint pain, lower backache, and sore feet, with accompanying sleeplessness.

Warnings

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

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a docotr or pharmacist.
  • with any other product containing dephenhydramine, even one used on skin
  • in children under 12 years of age

Ask Doctor

Ask a doctor before use if you have

  • liver disease
  • glaucoma
  • breathing problem such as asthma, emphysema, chronic bronchitis or pulmonary disease
  • trouble urinating due to an enlarged prostate gland
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes

Ask a doctor or pharmacist before use if you are

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

When using this product

When using this product

  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery
  • avoid alcoholic drinks

Stop Use

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 for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • symptoms do not improve within 7 days or are accompanied by a fever
  • new symptoms occur
  • redness or swelling is present
  • nervousness, dizziness or sleeplessness occur

If pregnany or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Directions

  • Do not exceed recommended dosage.

Adults and children 12 years of age and older

1 caplet at bedtime as needed, or as directed by a doctor
Children under 12 yearsconsult a doctor

Other Information

Other information

  • store at controlled room temperature 20° to 25° C (68° to 77° F)
  • avoid excessive heat and humidity
  • tamper evident. Do not use if carton is opened or neck wrap or foil inner seal is broken.
  • see end panel for lot number and expiration date.

Inactive Ingredients

Inactive ingredients

colloidal silicon dioxide, corn starch, FD&C blue #1, hydroxypropyl methylcellulose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid

Package Label. Principal Display Panel

LegatrinPM

Just 1 caplet

helps you sleep!

SAFE, NON-HABIT FORMING

Contains Acetaminophen,

Diphenhydramine HCI

LegatrinPM

Pain Reliever/Sleep Aid

Relieves lower

body pain

Leg Cramp Pain

Joint Pain

Lower Backache

Sore Feet

50 Caplets

LEGATRIN PM 
acetaminophen, diphenhydramine hci tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-907
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOLS 
POVIDONES 
SODIUM STARCH GLYCOLATE TYPE A CORN 
SILICON DIOXIDE 
STARCH, CORN 
FD&C BLUE NO. 1 
HYPROMELLOSES 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
Product Characteristics
ColorblueScoreno score
ShapeOVALSize17mm
FlavorImprint CodeLegatrin
Contains    
Packaging
#Item CodePackage Description
1NDC:10237-907-501 BOTTLE in 1 CARTON
150 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34310/01/2014
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIOperations
Church & Dwight Co., Inc.043690812label(10237-907)

 
Church & Dwight Co., 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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