| Heading | For people who don`t fool around with pain. |
| Purpose | Nighttime Sleep-Aid Pain Reliever |
| Manufacturer | J and J |
| Active Ingredients | In Each Caplet: Diphenhydramine Citrate 38 mg: Ibuprofen 200 mg (NSAID) (Nonsteroidal Anti-Inflammatory Drug) |
| 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. Read all directions and warnings before use. Keep carton. Store at 20-25 degrees C (68-77 degrees F). Avoid excessive heat above 40 degrees C (104 degrees F). |
| Inactive Ingredients | Colloidal Silicon Dioxide; Croscarmellose Sodium; Glyceryl Behenate; Hydroxypropyl Cellulose; Lactose Monohydrate; Magnesium Stearate; Microcrystalline Cellulose; Polyethylene Glycol; Polyvinyl Alcohol; Pregelatinized Starch; Talc; Titanium Dioxide |
| 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: the stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have high blood pressure heart disease liver cirrhosis or kidney disease; you are taking a diuretic; you have a breathing problem such as emphysema or chronic bronchitis; you have asthma; 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; 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 occur. 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). |
