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Ibuprofen PM by Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

Medically reviewed on Mar 26, 2018

Dosage form: capsule, liquid filled
Ingredients: IBUPROFEN 200mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
NDC Code: 55910-565

Drug Facts

Active ingredient (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:

  • 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 thining (antocoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • take more or for a longer time than directed
  • have 3 or more alcoholic drinks every day while using this product

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. TYhese can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use
  • in children under 12 years of age
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
  • unless you have time for a full night’s sleep
  • with any other product containing diphenhydramine, even one used on skin
  • if you have sleeplessness without pain

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 glaucoma
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke 
  • 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 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
  • taking any other drug
  • taking any other antihistamines
  • taking aspirin for heart attack or stroke, because ibuprofen may decease this benefit of aspirin
  • under a doctor's care for any continuing medical illness

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
    • have bloody or black stools
    • vomit blood
    • have stomach pain that does not get better
  • you have symptoms of heart problem or stroke:
    • chest pain
    • trouble breathing
    • leg swelling
    • slurred speech
    • weakness in one part or side of body
  • pain gets worse or last 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 (1-800-222-1222)

Directions
  • do not take more than directed
  • adults and childlren 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 20° to 25°C (68° to 77°F)
  • avoid high humidity and excessive heat above 40°C (104°F)
  • protect from light

Inactive ingredients

FD&C blue #1, FD&C red #40, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol

Questions or comments?

Call 1-888-309-9030

Principal Display Panel

Compare to the active ingredients of Advil® PM Liqui-Gels®**

SEE NEW WARNINGS

Ibuprofen PM Softgels

Ibuprofen 200 mg / Pain reliever (NSAID) 

Diphenhydramine HCl 25 mg / Nighttime Sleep-Aid

SOFTGELS**

(**liquid filled capsules)

**This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Advil® PM Liqui-Gels®.

TAMPER-EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL UNDER CAP  IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

Product Packaging

DOLLAR GENERAL HEALTH Ibuprofen PM Softgels

IBUPROFEN PM 
ibuprofen, diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-565
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
ColorBLUEScoreno score
ShapeOVALSize15mm
FlavorImprint CodeIBUPM
Contains    
Packaging
#Item CodePackage Description
1NDC:55910-565-201 BOTTLE, PLASTIC in 1 BOX
120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
2NDC:55910-565-401 BOTTLE, PLASTIC in 1 BOX
240 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09039702/29/2016
Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)

 
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

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Further information

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

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