good neighbor pharmacy ibuprofen pm
good neighbor pharmacy ibuprofen pm is an FDA drug label for the active ingredient DIPHENHYDRAMINE CITRATE, IBUPROFEN manufactured by Amerisource Bergen administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260515.
- Generic name
- DIPHENHYDRAMINE CITRATE, IBUPROFEN
- Manufacturer
- Amerisource Bergen
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 46122-708
- Application
- ANDA079113
- Label effective
- 20260515
About this product
good neighbor pharmacy ibuprofen pm is an FDA-registered drug product whose active ingredient is DIPHENHYDRAMINE CITRATE, IBUPROFEN. It is labelled by Amerisource Bergen taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 46122-708, application ANDA079113, label effective 20260515. It is one of 4 FDA drug label records sharing the active ingredient DIPHENHYDRAMINE CITRATE, IBUPROFEN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing DIPHENHYDRAMINE CITRATE, IBUPROFEN are most often described in connection with: relief occasional, minor aches, pains helps, fall asleep. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
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 caplets at bedtime • do not take more than 2 caplets in 24 hours
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 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 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 right away (1-800-222-1222).
More products with the same ingredient
DIPHENHYDRAMINE CITRATE, IBUPROFENHow products containing DIPHENHYDRAMINE CITRATE, IBUPROFEN compare
FDA lists 4 drug label records with DIPHENHYDRAMINE CITRATE, IBUPROFEN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | Amerisource Bergen | 1 |
| — | — | Meijer Distribution Inc | 1 |
| — | — | Strategic Sourcing Services LLC | 1 |
| — | — | WALMART INC. (see also Equate) | 1 |
| — | — | — | — |
Recall and safety notices
2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-1066-2013 | Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4496-22 | AmeriSource Bergen | Class II | Terminated | 20131009 |
| D-1065-2013 | Ifosfamide Injection 1g/20mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4495-22 | AmeriSource Bergen | Class II | Terminated | 20131009 |
Frequently asked questions
What is good neighbor pharmacy ibuprofen pm used for?
Uses • for relief of occasional sleeplessness when associated with minor aches and pains • helps you fall asleep and stay asleep
Who makes good neighbor pharmacy ibuprofen pm?
Amerisource Bergen is the labeler of record for good neighbor pharmacy ibuprofen pm. 4 FDA label records share the active ingredient DIPHENHYDRAMINE CITRATE, IBUPROFEN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.
What form does good neighbor pharmacy ibuprofen pm come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is good neighbor pharmacy ibuprofen pm prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Are there other products containing DIPHENHYDRAMINE CITRATE, IBUPROFEN?
Yes. 4 FDA drug label records list DIPHENHYDRAMINE CITRATE, IBUPROFEN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.
Has good neighbor pharmacy ibuprofen pm been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.