IBUPROFEN AND DIPHENHYDRAMINE HCL - ibuprofen and diphenhydramine hydrochloride capsule, liquid filled 
P and L Development of New York Corporation

----------

Active Ingredient (in each capsule)

Diphenhydramine hydrochloride 25mg

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)
(present as the free acid and potassium salt)
*non-steroidal anti-inflammatory drug

Purpose

Nighttime sleep-aid

Pain Reliever

Use

  • For relief of occasional sleeplessness when associated with minor aches and pains
  • Helps you fall asleep and stay asleep

Warnings

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, naproxin, 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

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


Stop use and ask a doctor if you are

  • taking sedatives or tranquilizers, or any other sleep-aid
  • taking any other drug containing an NSAID (prescription or nonprescription)
  • under a doctor's care for any continuing medical illness
  • taking any other antihistamines
  • taking a blood thinning (anticoagulant) or steriod drug
  • taking aspirin for heart attack or stroke, because ibuprofen may decease 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 last more than 10 dyas
  • sleepnessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness
  • stomach pain or upset gets worse or lasts
  • redness or swelling is present in the painful area
  • any new symptoms appear.
If pregnant of 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.

Directions


  • do not take more than directed
  • take 2 capsules at bedtime
  • do not take more than 2 capsules in 24 hours

Other information

  • each capsule contains: potassium 20mg
  • read all warnings and directions before use. Keep carton.
  • store at (20°-25°C (68°-77°F)
  • avoid high humidity and excessively heat above 40C (104F)
  • protect from light.

Inactive Ingredients

FDandC Blue #1, FDandC Red #40, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol

Questions or comments?

call toll free: 1-877-753-3935

This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® PM


Manufactured by: Banner Pharmacaps Inc.
4125 Premier Drive
High Point, NC 27265

Distributed by:
PL Developments
Westbury, NY 11590, USA


KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
THIS PRODUCT IS SEALED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE
USE ONLY IF THE BLISTERS ARE INTACT.

NDC 59726-165-32

*Compare to the active ingredients in Advil PM (R)

IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULES
200mg/25mg

32 Softgels
Pain Reliever (NSAID)
Nighttime Sleep-Aid



Product Packaging

Sleep Aid

IBUPROFEN AND DIPHENHYDRAMINE HCL 
ibuprofen, diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-165(NDC:10888-7142)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
POLYETHYLENE GLYCOLS 
POTASSIUM HYDROXIDE 
WATER 
SORBITAN 
SORBITOL 
Product Characteristics
Colorblue (BLUE) Scoreno score
ShapeOVAL (OVAL) Size19mm
FlavorImprint Code IBUPM
Contains    
Packaging
#Item CodePackage Description
1NDC:59726-165-321 in 1 BOX
132 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09039709/01/2011
Labeler - P and L Development of New York Corporation (800014821)

Revised: 09/2011
 
P and L Development of New York Corporation