ibuprofen pm diphenhydramine citrate, ibuprofen DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE IBUPROFEN IBUPROFEN SILICON DIOXIDE CROSCARMELLOSE SODIUM GLYCERYL DIBEHENATE HYDROXYPROPYL CELLULOSE (TYPE H) LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS TALC TITANIUM DIOXIDE POLYVINYL ALCOHOL FERROSOFERRIC OXIDE tablet L050
Drug Facts
Composition & Profile
Identifiers & Packaging
Principal Display Panel IBUPROFEN PM Ibuprofen and Diphenhydramine Citrate Tablets, 200 mg/38 mg Pain Reliever (NSAID)/ Nighttime Sleep-Aid COMPARE TO ADVIL® PM active ingredients †CAPSULE-SHAPED TABLETS Ibuprofen PM Carton Image 1 Ibuprofen PM Carton Image 1 Ibuprofen PM Carton Image 2 Ibuprofen PM Carton Image 1 Ibuprofen PM Carton Image 2
- Principal Display Panel IBUPROFEN PM Ibuprofen and Diphenhydramine Citrate Tablets, 200 mg/38 mg Pain Reliever (NSAID)/ Nighttime Sleep-Aid COMPARE TO ADVIL® PM active ingredients †CAPSULE-SHAPED TABLETS Ibuprofen PM Carton Image 1 Ibuprofen PM Carton Image 1 Ibuprofen PM Carton Image 2 Ibuprofen PM Carton Image 1 Ibuprofen PM Carton Image 2
Overview
Uses • for relief of occasional sleeplessness when associated with minor aches and pains • helps you fall asleep and stay asleep
Indications & Usage
Uses • for relief of occasional sleeplessness when associated with minor aches and pains • helps you fall asleep and stay asleep
Dosage & Administration
Directions • do not take more than directed • do not take longer than 10 days, unless directed by a doctor (see Warnings) • adults and children 12 years and over: take 2 caplets at bedtime • do not take more than 2 caplets in 24 hours
Warnings & Precautions
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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID [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 you have • a breathing problem such as emphysema or chronic bronchitis • problems or serious side effects from taking pain relievers or fever reducers • stomach problems that last or come back, such as heartburn, upset stomach or stomach pain • ulcers • bleeding problems • high blood pressure • heart or kidney disease • asthma • taken a diuretic • reached age 60 or over • glaucoma • 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 containing an NSAID (prescription or nonprescription) • under a doctor’s care for any continuing medical illness • taking any other antihistamines • taking a blood thinning (anticoagulant) or steroid drug • 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 • long term continuous use may increase the risk of heart attack or stroke Stop use and ask a doctor if • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding. • 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. • stomach pain or upset gets worse or lasts • 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.
Purpose
Purposes Nighttime sleep-aid Pain reliever
Do Not Use
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
When Using
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 • long term continuous use may increase the risk of heart attack or stroke
Stop Use & Ask a Doctor
Stop use and ask a doctor if • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding. • 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. • stomach pain or upset gets worse or lasts • redness or swelling is present in the painful area • any new symptoms appear
Keep Out of Reach of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Storage & Handling
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)
Questions
Questions or comments? 1-800-719-9260
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