Ibuprofen PM

TOP CARE (Topco Associates LLC)
P and L Development of New York Corporation

Ibuprofen PM softgels

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredients (in each capsule)
• Purpose
• Ibuprofen PM Uses
• Warnings
  • Do not use
  • Ask a doctor before use if
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant of breast-feeding,
  • Keep out of reach of children
• Directions
  • Ibuprofen PM Other information
• Inactive Ingredients
• Questions or comments?
• Principal Display Panel
• Product Label

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 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:

• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• are age 60 or older
• 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

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, or asthma
• 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

  • pain gets worse or last more than 10 days

  • sleepnessness 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 of 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 20°-25°C (68°-77° F)
• avoid high humidity and excessively heat above 40^o C (104^o 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 1-888-423-0139

Principal Display Panel

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

IBUPROFEN PM SOFTGELS

Solubilized Ibuprofen, 200 mg

Diphenhydramine HCl, 25 mg

PAIN RELIEVER (NSAID)*/ NIGHTTIME SLEEP-AID

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

Product Label