LEGATRIN PM- acetaminophen, diphenhydramine hci tablet 
Church & Dwight Co., Inc.

----------

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

LGFC-00114-03

LEGATRIN PM 
acetaminophen, diphenhydramine hci tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-907
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize17mm
FlavorImprint Code Legatrin
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-907-501 in 1 CARTON10/01/201412/31/2023
150 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUGM01310/01/201412/31/2023
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Co., Inc.043690812MANUFACTURE(10237-907)

Revised: 6/2024
 
Church & Dwight Co., Inc.