Ibuprofen PM

Wakefern Food Corporation

ShopRite Ibuprofen PM Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each caplet)
• Purposes
• 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 or breast-feeding,
  • Keep out of reach of children.
• Directions
• Ibuprofen PM Other information
• Inactive ingredients
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Diphenhydramine citrate 38 mg

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

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

• •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 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 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 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 children 12 years and over: take 2 caplets at bedtime
• •do not take more than 2 caplets in 24 hours

Ibuprofen PM Other information

• •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)

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl behenate, hydroxypropyl cellulose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

1-800-SHOPRITE

Principal Display Panel

Compare to: Active Ingredients in Advil® PM

SEE NEW WARNINGS INFORMATION

IBUPROFEN PM

Ibuprofen 200mg – Pain Reliever (NSAID)

Diphenhydramine Citrate 38mg

Nighttime Sleep-Aid Tablets

(**capsule shaped tablets)