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Active Ingredients (in Each Capsule)


Diphenhydramine hydrochloride 25 mgSolubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*(present as the free acid and potassium salt)*nonsteroidal anti-inflammatory drug

Purpose


Nighttime sleep-aidPain 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:
  • rash
  • facial swelling
  • bulers
  • hives
  • skin reddening
  • shock
  • asthma (wheezing)

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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
  • with any other product containing diphenhydramine, even one used on skin
  • right before or after heart surgery
  • if you have sleeplessness without pain

Ask a doctor before use if

  • 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 glaucoma
  • you have a breathing problem such as emphysema or chronic bronchitis
  • stomach bleeding warning applies to you
  • 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 any other drug
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

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.

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 20º-25ºC (68º-77ºF)
  • protect from light
  • avoid excessive heat above 40ºC (104ºF)

Inactive Ingredients


anidrisorb, D&C red no. 33, FD&C blue no. 1, gelatin, hydrolysed gelatin, medium chain triglyceride, opacode white ink, polyethylene glycol 600, potassium hydroxide, purified water.Ingredients of opacode white ink: lecithin (soya), n-butyl alcohol, purified water, shellac glaze in ethanol, simethicone and titanium dioxide.

Questions Or Comments?


Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel


QUALITYPLUS

NDC 50844-611-19

†Compare to theactive ingredients inAdvil® PM LIQUI-GELS®

IBUPROFEN PM SOFTGELS Ibuprofen 200 mg / Diphenhydramine HCl 25 mgPain Reliever (NSAID) / Nighttime Sleep-Aid

SEE NEW WARNINGS INFORMATION 

8 Softgels** **Liquid Filled Capsules

†This product is not manufactured or distributed byPfizer Consumer Healthcare, owner of the registeredtrademark Advil® PM LIQUI-GELS®.50844        ORG111261119

Product of India

Distributed by LNK INTERNATIONAL, INC. 60 Arkay Drive, Hauppauge, NY 11788USA

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Quality Plus 44-611

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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