Exchange Select Ibuprofen Pm
Diphenhydramine Citrate, Ibuprofen
Army & Air Force Exchange Service
Human Otc Drug
NDC 55301-050Exchange Select Ibuprofen Pm also known as Diphenhydramine Citrate, Ibuprofen is a human otc drug labeled by 'Army & Air Force Exchange Service'. National Drug Code (NDC) number for Exchange Select Ibuprofen Pm is 55301-050. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Exchange Select Ibuprofen Pm drug includes Diphenhydramine Citrate - 38 mg/1 Ibuprofen - 200 mg/1 . The currest status of Exchange Select Ibuprofen Pm drug is Active.
Drug Information:
| Drug NDC: | 55301-050 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Exchange Select Ibuprofen Pm |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Diphenhydramine Citrate, Ibuprofen |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Army & Air Force Exchange Service |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Film Coated |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | DIPHENHYDRAMINE CITRATE - 38 mg/1
IBUPROFEN - 200 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 28 Aug, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA079113 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Army & Air Force Exchange Service
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 895664
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000000160
M0001335
N0000175722
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 4OD433S209
WK2XYI10QM
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class MOA: | Cyclooxygenase Inhibitors [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Nonsteroidal Anti-inflammatory Drug [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Anti-Inflammatory Agents, Non-Steroidal [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic 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]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 55301-050-60 | 1 BOTTLE in 1 CARTON (55301-050-60) / 20 TABLET, FILM COATED in 1 BOTTLE | 28 Aug, 2015 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purposes nighttime sleep-aid pain reliever
Product Elements:
Exchange select ibuprofen pm diphenhydramine citrate, ibuprofen diphenhydramine citrate diphenhydramine ibuprofen ibuprofen silicon dioxide croscarmellose sodium fd&c blue no. 2 glyceryl dibehenate hydroxypropyl cellulose (1600000 wamw) ferrosoferric oxide lactose monohydrate magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified talc titanium dioxide l050
Indications and Usage:
Uses ⢠for relief of occasional sleeplessness when associated with minor aches and pains ⢠helps you fall asleep and stay asleep
Warnings:
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 warning: nsaids, except aspirin, increase the risk of heart attack, heart failure, and stroke. these can be fatal. the risk is highe
Read more...r 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 nightâs 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 ⢠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 gland ask a doctor or pharmacist before use if you are ⢠taking sedatives or tranquilizers, or any other sleep-aid ⢠under a doctorâs 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 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 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 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. (1-800-222-1222)
Do Not Use:
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 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 nightâs 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 ⢠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 gland ask a doctor or pharmacist before use if you are ⢠taking sedatives or tranquilizers, or any other sleep-aid ⢠under a doctorâs 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 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 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 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. (1-800-222-1222)
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
Dosage and Administration:
Directions ⢠do not take more than directed ⢠adults and children 12 years and over: take 2 caplets at bedtime ⢠do not take more than 2 caplets in 24 hours
Stop Use:
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 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 appear
Package Label Principal Display Panel:
Principal display panel compare to the active ingredients of advil ® pm caplets see new warnings ibuprofen pm ibuprofen 200 mg/diphenhydramine citrate 38 mg tablets pain reliever (nsaid)/nighttime sleep-aid caplets actual size 20 coated caplets** **capsule-shaped tablets quality value ibuprofen pm image
Further Questions:
Questions or comments? 1-800-719-9260