ADVIL PM (diphenhydramine hydrochloride 25 mg ibuprofen 200 mg) Dailymed
Generic: diphenhydramine hcl, ibuprofen is used for the treatment of Anxiety Disorders Infant, Newborn Infant, Premature Sleep Initiation and Maintenance Disorders Lactation Motion Sickness Nausea Rhinitis, Allergic, Perennial Sneezing Status Asthmaticus Urticaria Arthritis, Juvenile Arthritis, Rheumatoid Asthma Bursitis Dysmenorrhea Fever Gout Inflammation Menorrhagia Osteoarthritis Pain Pain, Postoperative Pregnancy Trimester, Third Pregnancy, Abdominal Premenstrual Syndrome Rhinitis Spondylitis, Ankylosing Bronchial Hyperreactivity
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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)
*nonsteroidal anti-inflammatory drug
Purposes
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• bulers
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 directedHeart 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 painAsk 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, 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 glandAsk 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 drugWhen 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 occursStop 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• 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 medical illness.• redness or swelling is present in the painful area• any new symptoms appearIf pregnant or breast-feeding,
ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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 excessive heat above 40°C (104°F)• protect from light
Inactive Ingredients
D&C red no. 33, FD&C blue no. 1, gelatin, medium-chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution
Questions Or Comments?
Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL
Additional Information
Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing.
For most recent product information, visit www.Advil.com
Dist. by: GSK CH, Warren, NJ 07059
Trademarks owned or licensed by GSK ©2021 GSK or licensor
Patents: www.productpats.com
LIQUI-GELS® is a trademark or registered trademark
of Catalent Pharma Solutions.
Principal Display Panel
NDC 0573-0167-25
Advil® PM LIQUI•GELS®
Solubilized Ibuprofen, 200 mg /Diphenhydramine HCl, 25 mgPain Reliever (NSAID)/Nighttime Sleep-Aid
20 Liquid Filled Capsules
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