Ibuprofen 200 Mg And Diphenhydramine Citrate 38 Mg Tablet
FDA Label NDC 63548-0197

Diphenhydramine citrate 38 mg

Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Nighttime sleep-aid

Pain reliever

• for relief of occasional sleeplessness when associated with minor aches and pains
• helps you fall asleep and stay asleep

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

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 longer than directed.

• 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

• 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

• 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
• take any other drug

• drowsiness will occur
• avoid alcoholic drinks
• do not drive a motor vehicle or operate machinery
• take with food or milk if stomach upset occurs

• 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
  • you have symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling
    • 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 illness
    • redness or swelling is present in the painful area
    • any new symptoms appear

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.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

• read all warnings and directions before use. Keep carton.
• store between 20-25°C (68-77°F)
• avoid excessive heat above 40°C (104°F)
  

carnauba wax, corn starch, croscarmellose sodium, FD&C blue #2, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol 400, silicon dioxide, stearic acid, titanium dioxide

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

†Compare to the active ingredients in Advil®PM Caplets

Ibuprofen and Diphenhydramine Citrate Tablets

200 mg/38 mg

Pain reliever (NSAID)/Nighttime sleep-aid

20 Coated caplets**

(**Capsule-shaped tablets)

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Advil® PM Caplets.

Manufactured by:
Avéma Pharma Solutions
10400 NW 29th Terrace, Miami, FL 33172