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| Product NDC Code | 64380-732 | ||||||||||||||||||||
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| Drug Name | Ibuprofen and diphenhydramine hcl |
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| Type | Generic | ||||||||||||||||||||
| 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 | CAPSULE, LIQUID FILLED | ||||||||||||||||||||
| RxCUI drug identifier | 901814 | ||||||||||||||||||||
| Application Number | ANDA200888 | ||||||||||||||||||||
| Labeler Name | Strides Pharma Science Limited | ||||||||||||||||||||
| 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 ingredients (in each capsule) Purposes Diphenhydramine hydrochloride 25 mg…………………………………...Nighttime sleep-aid Solubilized ibuprofen equal to ibuprofen 200 mg (NSAID)*……………...Pain reliever (present as the free acid and potassium salt) *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 children 12 years and over: take 2 capsules at bedtime do not take more than 2 capsules in 24 hours Other information • each capsule contains: potassium 20 mg • 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) • protect from light
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Anidrisorb, D&C red no. 33, FD&C blue no. 1, gelatin, Hydrolyzed gelatin, medium chain triglyceride. Opacode white ink, Polyethylene glycol 600, potassium hydroxide, purified water. Ingredients of Opacode white ink: shellac glaze in ethanol, titanium dioxide, n-butyl alcohol, lecithin (soya), simethicone and purified water.
Spl product data elements
Usually a list of ingredients in a drug product.IBUPROFEN AND DIPHENHYDRAMINE HCL IBUPROFEN AND DIPHENHYDRAMINE HCL DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE IBUPROFEN IBUPROFEN D&C RED NO. 33 FD&C BLUE NO. 1 GELATIN MEDIUM-CHAIN TRIGLYCERIDES POTASSIUM HYDROXIDE WATER SORBITAN SORBITOL POLYETHYLENE GLYCOL 600 Bluish purple color 1007
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.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 180 s count container label 20 s count container label 20 s count carton label 180 s carton label 180 s count container label 20 s count container label 20 s count carton label 180 s carton label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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 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 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 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
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 heart surgery with any other product containing diphenhydramine, even one used on skin if you have sleeplessness without pain
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 at 1877 244 9825 Manufactured by: Strides Pharma Science Limited Bengaluru - 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 Revised: 01/2022
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 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
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. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.Uses for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
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 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.
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