LEGATRIN PM- acetaminophen and diphenhydramine hydrochloride tablet 
Lil' Drug Store Products, 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®

Drug Facts

Active ingredients (in each caplet)Purposes
Acetaminophen 500 mgPain Reliever
Diphenhydramine HCl 50 mgSleep Aid

Uses

temporary relief of minor aches and pains, such as leg cramp pain, joint pain, lower backache, and sore feet, 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 other product containing diphenhydramine, even one used on skin
  • in children under 12 years of age

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

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

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

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

  • Do not exceed recommended dosage.
Adults and children 12 years of age and older1 caplet at bedtime as needed, or as directed by a doctor.
Children under 12 yearsconsult a doctor

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

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

Questions or comments?

1-877-507-6516 (M-F 8 AM-4:30 PM CST) or www.legatrinpm.com

DISTRIBUTED BY:
Lil' Drug Store Products, Inc.
1201 Continental Place NE
Cedar Rapids, IA 52402

PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton

Legatrin PM®
Pain Reliever/Sleep Aid

Just 1 caplet helps you sleep!

Relieves lower body pain,
including leg cramp pain.

Contains Acetaminophen,
Diphenhydramine HCl

SAFE, NON-HABIT FORMING

50 Caplets

Principal Display Panel - 50 Caplet Bottle Carton
LEGATRIN PM 
acetaminophen and diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-4905
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
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Starch, Corn (UNII: O8232NY3SJ)  
FD&C blue NO. 1 (UNII: H3R47K3TBD)  
hypromellose, unspecified (UNII: 3NXW29V3WO)  
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
povidone, unspecified (UNII: FZ989GH94E)  
microcrystalline cellulose (UNII: OP1R32D61U)  
Maltodextrin (UNII: 7CVR7L4A2D)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize17mm
FlavorImprint Code Legatrin
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66715-4905-01 in 1 CARTON11/02/200909/30/2014
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 FINALpart34311/02/200909/30/2014
Labeler - Lil' Drug Store Products, Inc (093103646)

Revised: 1/2017
 
Lil' Drug Store Products, Inc