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Ibuprofen PM by L.N.K. International, Inc.

Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg, IBUPROFEN 200mg
Labeler: L.N.K. International, Inc.
NDC Code: 50844-611

Quality Plus 44-611

Active ingredients (in each capsule)

Diphenhydramine hydrochloride 25 mg
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 

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:

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

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 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
  • with any other product containing diphenhydramine, even one used on skin
  • right before or after heart surgery
  • if you have sleeplessness without pain 

Ask a doctor before use if
  • if 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 glaucoma
  • you have a breathing problem such as emphysema or chronic bronchitis
  • stomach bleeding warning applies to you
  • 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 any other drug
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

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.

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

Other information
  • each capsule contains: potassium 20 mg
  • read all warnings and directions before use.
    Keep carton
  • store at 20º-25ºC (68º-77ºF)
  • protect from light
  • avoid excessive heat above 40ºC (104ºF)

Inactive ingredients

anidrisorb, D&C red no. 33, FD&C blue no. 1, gelatin, hydrolysed gelatin, medium chain triglyceride, opacode white ink, polyethylene glycol 600, potassium hydroxide, purified water.
ingredients of opacode white ink: lecithin (soya), n-butyl alcohol, purified water, shellac glaze in ethanol, simethicone and titanium dioxide.

Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00PM ET, Monday-Friday

Principal display panel

QUALITY PLUS

NDC 50844-611-19

†Compare to the active ingredients in Advil® PM LIQUI-GELS®

IBUPROFEN PM
SOFTGELS
Ibuprofen 200 mg / Diphenhydramine HCl 25 mg
Pain Reliever (NSAID) / Nighttime  Sleep-Aid

SEE NEW WARNINGS INFORMATION 

8 Softgels**
**Liquid Filled Capsules

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® PM LIQUI-GELS®.
50844        ORG111261119

Product of India

Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
USA

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING

Quality Plus 44-611

IBUPROFEN PM 
diphenhydramine hydrochloride, ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-611
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
GELATIN 
MEDIUM-CHAIN TRIGLYCERIDES 
POLYETHYLENE GLYCOL 600 
POTASSIUM HYDROXIDE 
WATER 
LECITHIN, SOYBEAN 
SHELLAC 
TITANIUM DIOXIDE 
Product Characteristics
ColorPURPLE (bluish tint) Scoreno score
ShapeOVALSize15mm
FlavorImprint Code1007
Contains    
Packaging
#Item CodePackage Description
1NDC:50844-611-191 BLISTER PACK in 1 CARTON
18 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20088807/08/2013
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(50844-611)
Establishment
NameAddressID/FEIOperations
Strides Arcolab Limited918513263API MANUFACTURE(50844-611)

 
L.N.K. International, Inc.

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Medically reviewed on Jun 13, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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