Ibuprofen PM Diphenhydramine hydrochloride, ibuprofen DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE IBUPROFEN IBUPROFEN D&C RED NO. 33 FD&C BLUE NO. 1 GELATIN, UNSPECIFIED MEDIUM-CHAIN TRIGLYCERIDES POLYETHYLENE GLYCOL 600 POTASSIUM HYDROXIDE WATER SORBITOL SORBITAN bluish tint 1007
Drug Facts
Composition & Profile
Identifiers & Packaging
Principal Display Panel QUALITY PLUS NDC 50844-611-19 †Compare to the active ingredients in Advil® PM LIQUI-GELS® IBUPROFEN PM SOFTGELS Ibuprofen 200 mg / Diphenhydramine HCl 25 mg Pain Reliever (NSAID) / Nighttime Sleep-Aid SEE NEW WARNINGS INFORMATION 8 Softgels** **Liquid Filled Capsules †This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® PM LIQUI-GELS®. 50844 ORG111261119 Product of India Distributed by LNK INTERNATIONAL, INC. 60 Arkay Drive, Hauppauge, NY 11788 USA 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 Quality Plus 44-611
- Principal Display Panel QUALITY PLUS NDC 50844-611-19 †Compare to the active ingredients in Advil® PM LIQUI-GELS® IBUPROFEN PM SOFTGELS Ibuprofen 200 mg / Diphenhydramine HCl 25 mg Pain Reliever (NSAID) / Nighttime Sleep-Aid SEE NEW WARNINGS INFORMATION 8 Softgels** **Liquid Filled Capsules †This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® PM LIQUI-GELS®. 50844 ORG111261119 Product of India Distributed by LNK INTERNATIONAL, INC. 60 Arkay Drive, Hauppauge, NY 11788 USA 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 Quality Plus 44-611
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 adults and children 12 years and over: take 2 capsules at bedtime do not take more than 2 capsules in 24 hours
Warnings & Precautions
Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: rash facial swelling blisters 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.
Purpose
Purpose 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 with any other product containing diphenhydramine, even one used on skin right before or after heart surgery 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 the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stop Use & Ask a Doctor
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
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 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)
Questions
Questions or comments? Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
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