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| Product NDC Code | 21130-056 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Ibuprofen pm |
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| Type | Brand | ||||||
| Pharm Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | TABLET, COATED | ||||||
| RxCUI drug identifier | 895664 | ||||||
| Application Number | ANDA211404 | ||||||
| Labeler Name | Safeway, Inc. | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each caplet) Diphenhydramine citrate 38 mg ibuprofen 200 mg(NSAID)* *nonsteroidal anti-inflammatory drug
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions do not take more than directed adults and childlren 12 years and over: take 2 caplets at bedtime do not take more than 2 caplets in 24 hours
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carnauba wax, corn starch, croscarmellose sodium,FD&C blue #2, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol 400, silicon dioxide, stearic acid, titanium dioxide
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
Purpose
Information about the drug product’s indications for use.Purpose Nighttime sleep-aid Pain Reliever
Spl product data elements
Usually a list of ingredients in a drug product.Ibuprofen PM Diphenhydramine Citrate, Ibuprofen IBUPROFEN IBUPROFEN DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE CARNAUBA WAX STARCH, CORN CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 HYPROMELLOSE, UNSPECIFIED CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOL 400 SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE PL72
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel COMPARE TO Advil® PM active ingredients† Ibuprofen PM IBUPROFEN 200 mg Pain reliever (NSAID) Diphenhydramine citrate 38 mg Nighttime sleep-aid COATED CAPLETS** (**capsules-shaped tablets) †This product is not manufactured or distributed by Haleon Group of Companies, distributor Advil® PM TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. DISTRIBUTED BY BETTER LIVING BRANDS LLC P.O. BOX 99 PLEASANTON, CA 94566-0009
Product Packaging SIGNATURE CARE Ibuprofen PM Diphenhydramine Citrate 38 mg, Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if the stomach bleeding warning applies to you you have problem 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 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 gland
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.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 decease this benefit of aspirin taking any other drug
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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 surgery with any other product containing diphenhydramine, even one used on skin if you have sleeplessness without pain
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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 you have symptoms of heart problem or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or last 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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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.
Storage and handling
Information about safe storage and handling of the drug product.Other information read all warnings and directions before use. Keep carton. store between 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 Heart attack and stroke warnin g: 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 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 problem 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 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 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 decease 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 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 you have symptoms of heart problem or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or last 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 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 (1-800-222-1222) right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API