Motrin PM

Dosage form: tablet, coated
Ingredients: Ibuprofen 200mg, Diphenhydramine Citrate 38mg
Labeler: McNeil Consumer Healthcare Div McNeil-PPC, Inc
NDC Code: 50580-563

Motrin® PM

Drug Facts

Active ingredients (in each caplet)Purposes
nonsteroidal anti-inflammatory drug
Diphenhydramine citrate 38 mgNighttime sleep-aid
Ibuprofen 200 mg (NSAID)Pain reliever

Uses
  • for relief of occasional sleeplessness when associated with minor aches and pains
  • helps you fall asleep and stay asleep

Warnings

Allergy alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if you

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Do not use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • unless you have time for a full night's sleep
  • in children under 12 years of age
  • right before or after heart surgery
  • with any other product containing diphenhydramine, even one used on skin
  • if you have sleeplessness without pain

Ask a doctor before use if
  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
  • you are taking a diuretic
  • you have a breathing problem such as emphysema or chronic bronchitis
  • you have glaucoma
  • you have trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are
  • taking sedatives or tranquilizers, or any other sleep-aid
  • under a doctor's care for any continuing medical illness
  • taking any other antihistamines
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

When using this product
  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery
  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • redness or swelling is present in the painful area
  • any new symptoms appear

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions
  • do not take more than directed
  • adults and children 12 years and over:
    take 2 caplets at bedtime
  • do not take more than 2 caplets in 24 hours

Other information
  • read all warnings and directions before use. Keep carton.
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, glyceryl behenate, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Questions or comments?

call 1-800-962-5357 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

NDC 50580-563-80

Motrin® PM

Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg Tablets
Pain Reliever (NSAID)/Nighttime Sleep-Aid

80 Coated Caplets**

**Capsule-Shaped Tablets

CAPLETS**

MOTRIN   PM
ibuprofen and diphenhydramine citrate tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-563
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ibuprofen (Ibuprofen) Ibuprofen200 mg
Diphenhydramine Citrate (Diphenhydramine) Diphenhydramine Citrate38 mg
Inactive Ingredients
Ingredient NameStrength
silicon dioxide 
croscarmellose sodium 
glyceryl dibehenate 
hydroxypropyl cellulose (Type E) 
lactose monohydrate 
magnesium stearate 
cellulose, microcrystalline 
polyethylene glycols 
polyvinyl alcohol 
talc 
titanium dioxide 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize15mm
FlavorImprint CodeMOTRIN;PM
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-563-201 BOTTLE, PLASTIC in 1 CARTON
120 TABLET, COATED in 1 BOTTLE, PLASTIC
2NDC:50580-563-401 BOTTLE, PLASTIC in 1 CARTON
240 TABLET, COATED in 1 BOTTLE, PLASTIC
3NDC:50580-563-801 BOTTLE, PLASTIC in 1 CARTON
380 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07911301/11/2010
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 12/2013
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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