LEGATRIN PM- acetaminophen, diphenhydramine hci tablet

Legatrin PM by

Drug Labeling and Warnings

Legatrin PM by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc., ULTRAtab. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

LEGATRIN PM 
acetaminophen, diphenhydramine hci tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-907
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50

Inactive Ingredients
Ingredient Name	Strength
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
Color	blue	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	Legatrin
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-907-50	1 in 1 CARTON	10/01/2014
1		50 in 1 BOTTLE; Type 0: Not a Combination Product

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	Business Operations
Church & Dwight Co., Inc.		043690812	label(10237-907)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab		151051757	manufacture(10237-907)