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NDC 69452-0205-11 IBUPROFEN, DIPHENHYDRAMINE HCL 25; 200 mg/1; mg/1 Details
IBUPROFEN, DIPHENHYDRAMINE HCL 25; 200 mg/1; mg/1
IBUPROFEN, DIPHENHYDRAMINE HCL is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Bionpharma Inc.. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN.
MedlinePlus Drug Summary
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 69452-0205-11Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine
Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). It is also used to relieve mild to moderate pain, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription ibuprofen is used to reduce fever and to relieve minor aches and pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Ibuprofen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.
Related Packages: 69452-0205-11Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ibuprofen
Product Information
| NDC | 69452-0205 |
|---|---|
| Product ID | 69452-205_0f6b5911-edb2-4e3a-b121-45c609b4c60e |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | IBUPROFEN, DIPHENHYDRAMINE HCL |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | IBUPROFEN, DIPHENHYDRAMINE HCL |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CAPSULE, LIQUID FILLED |
| Route | ORAL |
| Active Ingredient Strength | 25; 200 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN |
| Labeler Name | Bionpharma Inc. |
| Pharmaceutical 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] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090397 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 69452-0205-11 (69452020511)
| NDC Package Code | 69452-205-11 |
|---|---|
| Billing NDC | 69452020511 |
| Package | 20 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-11) |
| Marketing Start Date | 2018-11-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 59a97c31-db90-48e1-ac1b-0f7026c8ec94 Details
Active ingredients (in each capsule)
Uses
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 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
■ 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 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
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
Directions
Other information
Inactive ingredients
Questions or comments?
Principal Display Panel
BIONPHARMA
NDC 69452-205-20
Ibuprofen and Diphenhydramine HCL
200 mg/25 mg
Solubilized Ibuprofen, 200 mg/
Diphenhydramine HCl, 25 mg
Pain Reliever (NSAID)/Nighttime Sleep-Aid
DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.
100 Capsules
Softgels**
**Liquid filled capsules
INGREDIENTS AND APPEARANCE
| IBUPROFEN, DIPHENHYDRAMINE HCL
ibuprofen, diphenhydramine hcl capsule, liquid filled |
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| Labeler - Bionpharma Inc. (079637826) |
| Registrant - Bionpharma Inc. (079637826) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Patheon Softgels Inc. | 002193829 | manufacture(69452-205) | |