MAJOR IBUPROFEN PM - diphenhydramine citrate and ibuprofen tablet, coated 
Major Pharmaceuticals

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Major Ibuprofen PM Drug Facts

Active ingredient (in each caplet)

Diphenhydramine citrate 38 mg

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Nighttime sleep-aid

Pain reliever

Uses

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

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

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding.

The chance is higher if you:

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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 the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl behenate, hydroxypropyl cellulose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Questions or comments? 

1-800-719-9260

Principal Display Panel

Ibuprofen PM

Ibuprofen and Diphenhydramine Citrate Tablets, 200 mg/38 mg

Pain Reliever (NSAID)/Nighttime Sleep-Aid

Compare to the active ingredients of Advil® PM

**Capsule-Shaped Tablets

Product Carton

Product Carton

Product Label

Product Label


MAJOR IBUPROFEN  PM
diphenhydramine citrate and ibuprofen   tablet, coated
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0904-5877
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE CITRATE (DIPHENHYDRAMINE) DIPHENHYDRAMINE CITRATE38 mg
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
ColorBLUEScore no score
ShapeCAPSULE (tablet) Size15mm
FlavorImprint Code L050
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10904-5877-951 BOTTLE In 1 CARTONcontains a BOTTLE (0904-5877-95)
10904-5877-9520 TABLET In 1 BOTTLEThis package is contained within the CARTON (0904-5877-95)
20904-5877-391 BOTTLE In 1 CARTONcontains a BOTTLE (0904-5877-39)
20904-5877-3940 TABLET In 1 BOTTLEThis package is contained within the CARTON (0904-5877-39)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07911306/08/2009

Labeler - Major Pharmaceuticals (191427277)
Revised: 07/2009Major Pharmaceuticals