Ibuprofen PM: Package Insert and Label Information

IBUPROFEN PM- ibuprofen and diphenhydramine hydrochloride capsule, liquid filled
Walgreens

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 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 than directed

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

  • the 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, asthma or had a stroke
  • 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 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 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

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 problems 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 excessive heat above 40°C (104°F)
  • swallow whole; do not crush, chew, or dissolve
  • protect from light

Inactive ingredients

D&C red #33,FD&C blue #1, gelatin, medium chain triglycerides, polyethylene glycol 600, potassium hydroxide, purified water, sorbitan, sorbitol

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

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

Ibuprofen PM

IBUPROFEN CAPSULES 200 mg / PAIN RELIEVER (NSAID)

DIPHENHYDRAMINE HCl, 25 mg / NIGHTTIME SLEEP AID

NIGHTTIME SOFTGELS

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 PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

Product Packaging

Diphenhydramine HCI 25 mg Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug
(click image for full-size original)

WALGREENS Ibuprofen PM

IBUPROFEN PM
ibuprofen, diphenhydramine hcl capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0756
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
D&C RED NO. 33
GELATIN
POLYETHYLENE GLYCOL 600
POTASSIUM HYDROXIDE
WATER
SORBITAN
SORBITOL
MEDIUM-CHAIN TRIGLYCERIDES
Product Characteristics
Color PURPLE Score no score
Shape OVAL Size 16mm
Flavor Imprint Code 1007
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0756-40 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
1 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC This package is contained within the BOX (0363-0756-40)
2 NDC:0363-0756-20 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
2 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC This package is contained within the BOX (0363-0756-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200888 07/31/2018
Labeler — Walgreens (008965063)

Revised: 10/2019 Walgreens

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