Legatrin PM: Package Insert and Label Information

LEGATRIN PM- acetaminophen and diphenhydramine hydrochloride 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.

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 years consult 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
(click image for full-size original)
LEGATRIN PM
acetaminophen, diphenhydramine hci tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-907
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 50
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 400
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A CORN
SILICON DIOXIDE
STARCH, CORN
FD&C BLUE NO. 1
HYPROMELLOSES
MALTODEXTRIN
MICROCRYSTALLINE CELLULOSE
STEARIC ACID
Product Characteristics
Color blue Score no score
Shape OVAL Size 17mm
Flavor Imprint Code Legatrin
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10237-907-50 1 BOTTLE in 1 CARTON contains a BOTTLE
1 50 TABLET in 1 BOTTLE This package is contained within the CARTON (10237-907-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 10/01/2014
Labeler — Church & Dwight Co., Inc. (001211952)
Establishment
Name Address ID/FEI Operations
Church & Dwight Co., Inc. 043690812 label (10237-907)
Establishment
Name Address ID/FEI Operations
ULTRAtab 151051757 manufacture (10237-907)

Revised: 10/2019 Church & Dwight Co., Inc.

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