Ibuprofen PM description, usages, side effects, indications, overdosage, supplying and lots more!

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Ibuprofen PM

L.N.K. International, Inc.

Quality Plus 44-611


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 

Ibuprofen PM Uses

  • for relief of occassional 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 aspirn.  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 nore or for a longer time than directed 

Do not use

  • if you have ever had an allergic reaciton 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
  • night 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 hight 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 tranquilziers, or any other sleep-aid
  • under a doctor's care ofr any continuingmedical 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 problem.
  • redness or swellig 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 

Ibuprofen PM 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 head above 40ºC (104ºF)

Inactive ingredients

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

Ibuprofen PM
Quality Plus 44-611

Ibuprofen PM

Diphenhydramine hydrochloride, ibuprofen CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50844-611
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg
IBUPROFEN IBUPROFEN 200 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 1
GELATIN
MEDIUM-CHAIN TRIGLYCERIDES
POLYETHYLENE GLYCOL 600
POTASSIUM HYDROXIDE
water
LECITHIN, SOYBEAN
SHELLAC
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
PURPLE (bluish tint) 16 mm 1007 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 8 in 1 BLISTER PACK
2 NDC:50844-611-19 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200888 2013-07-08


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Be sure to consult your doctor before taking any medication!
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