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Ibuprofen PM by LNK International, Inc.

Dosage form: capsule, liquid filled
Ingredients: IBUPROFEN 200mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: LNK International, Inc.
NDC Code: 50844-732

IBUPROFEN PM

DRUG FACTS

ACTIVE INGREDIENT

Active Ingredient(s)                                                                  

(In each capsule)

Diphenhydramine hydrochloride 25 mg

Solubilized Ibuprofen equal to Ibuprofen 200 mg (NSAID)* (Present as the free acid and potassium salt)

*nonsteroidal 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:

  •   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 DOCTOR/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 medical overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS
  1. do not take more than directed
  2. adults and children 12 years and over: take 2 capsules at bedtime
  3. 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 20-25°C (68-77°F)
  •   Avoid excessive heat above 40°C (104°F)
  •   Protect from light

INACTIVE INGREDIENT

Anidrisorb, D&C red no. 33, FD&C blue no. 1, gelatin, Hydrolyzed gelatin, medium chain triglyceride. Opacode white ink, Polyethylene glycol 600, potassium hydroxide, purified water.

Ingredients of Opacode white ink: shellac glaze in ethanol, titanium dioxide, n-butyl alcohol, lecithin (soya), simethicone and purified water.

QUESTIONS OR COMMENTS?

Call 1-800-426-9391 

8:30 AM to 4:00 PM ET, Monday-Friday

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CARTON LABEL

IBUPROFEN PM 
ibuprofen and diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-732
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
D&C RED NO. 33 
FD&C BLUE NO. 1 
GELATIN 
MEDIUM-CHAIN TRIGLYCERIDES 
POTASSIUM HYDROXIDE 
WATER 
SORBITAN 
SORBITOL 
SHELLAC 
TITANIUM DIOXIDE 
BUTYL ALCOHOL 
LECITHIN, SOYBEAN 
POLYETHYLENE GLYCOL 600 
Product Characteristics
ColorPURPLE (Bluish purple color) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code1007
Contains    
Packaging
#Item CodePackage Description
1NDC:50844-732-212 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
ANDAANDA20088803/05/2012
Labeler - LNK International, Inc. (038154464)
Registrant - Strides Arcolab Limited (650738743)

 
LNK International, Inc.

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Medically reviewed on Nov 29, 2017

Further information

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

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