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

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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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:

Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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

Do not use

Do not use

Ask Doctor

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

When using this product

Stop Use

Stop use and ask a doctor if

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

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

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 
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE (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)  
HYPROMELLOSES (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 CARTON10/01/2014
150 in 1 BOTTLE; Type 0: Not a Combination Product
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/FEIBusiness Operations
Church & Dwight Co., Inc.043690812label(10237-907)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab151051757manufacture(10237-907)

Revised: 10/2019
Document Id: 2dcf1c25-6dcb-4891-87f8-f33908d7357f
Set id: 058be7e6-01cb-5cd6-e054-00144ff88e88
Version: 5
Effective Time: 20191001
 
Church & Dwight Co., Inc.