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ibuprofen pm
diphenhydramine citrate, ibuprofen · Tablet, Film Coated
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Anti-Inflammatory Agents | EPC | All 251 members |
| Cyclooxygenase Inhibitors [MoA] | MoA | All 251 members |
| Histamine H1 Receptor Antagonists [MoA] | MoA | All 136 members |
| Histamine-1 Receptor Antagonist [EPC] | EPC | All 134 members |
| Non-Steroidal [CS] | CS | All 251 members |
| Nonsteroidal Anti-inflammatory Drug [EPC] | EPC | All 251 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 079113-001 | IBUPROFEN AND DIPHENHYDRAMINE CITRATE | TABLET | DIPHENHYDRAMINE CITRATE; IBUPROFEN | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 21 | Manufacturing (CMC) | Approved | November 2, 2016 | Unknown |
| Supplement | 5 | Labeling | Approved | December 31, 2014 | — |
| Original application | 1 | Approved | December 22, 2008 | — |
Review documents
- 0 · Original application · March 28, 2012
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251024). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses • for relief of occasional sleeplessness when associated with minor aches and pains • helps you fall asleep and stay asleep
Purpose
openFDA Drug LabelingPurposes Nighttime sleep-aid Pain reliever
Dosage and Administration
openFDA Drug LabelingDirections • 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
openFDA Drug LabelingWarnings 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).
Do Not Use
openFDA Drug LabelingDo 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
openFDA Drug LabelingAsk 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
Stop Use
openFDA Drug LabelingStop 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
Active Ingredient
openFDA Drug LabelingActive ingredients (in each caplet) Diphenhydramine citrate 38 mg Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: IBUPROFEN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 59779-050-27 | 59779-050 | CVS Pharmacy | 1 BOTTLE in 1 CARTON (59779-050-27) / 80 TABLET, FILM COATED in 1 BOTTLE | February 17, 2009 |
| 59779-050-60 | 59779-050 | CVS Pharmacy | 1 BOTTLE in 1 CARTON (59779-050-60) / 20 TABLET, FILM COATED in 1 BOTTLE | May 1, 2009 |
| 59779-050-76 | 59779-050 | CVS Pharmacy | 1 BOTTLE in 1 CARTON (59779-050-76) / 120 TABLET, FILM COATED in 1 BOTTLE | April 27, 2015 |
| 59779-050-82 | 59779-050 | CVS Pharmacy | 200 TABLET, FILM COATED in 1 BOTTLE (59779-050-82) | September 12, 2017 |
| 37808-703-60 | 37808-703 | H E B | 1 BOTTLE in 1 CARTON (37808-703-60) / 20 TABLET, FILM COATED in 1 BOTTLE | April 5, 2018 |
| 42507-050-27 | 42507-050 | HyVee Inc | 1 BOTTLE in 1 CARTON (42507-050-27) / 80 TABLET, FILM COATED in 1 BOTTLE (42507-050-80) | March 2, 2009 |
| 30142-050-27 | 30142-050 | Kroger Company | 1 BOTTLE in 1 CARTON (30142-050-27) / 80 TABLET, FILM COATED in 1 BOTTLE | April 6, 2009 |
| 30142-050-60 | 30142-050 | Kroger Company | 1 BOTTLE in 1 CARTON (30142-050-60) / 20 TABLET, FILM COATED in 1 BOTTLE | April 6, 2009 |
| 41250-050-58 | 41250-050 | Meijer Distribution Inc | 1 BOTTLE in 1 CARTON (41250-050-58) / 40 TABLET, FILM COATED in 1 BOTTLE | April 8, 2009 |
| 41250-050-60 | 41250-050 | Meijer Distribution Inc | 1 BOTTLE in 1 CARTON (41250-050-60) / 20 TABLET, FILM COATED in 1 BOTTLE (41250-050-20) | March 5, 2026 |
| 41250-050-76 | 41250-050 | Meijer Distribution Inc | 1 BOTTLE in 1 CARTON (41250-050-76) / 120 TABLET, FILM COATED in 1 BOTTLE | October 21, 2017 |
| 56062-050-58 | 56062-050 | Publix Super Markets Inc | 1 BOTTLE in 1 CARTON (56062-050-58) / 40 TABLET, FILM COATED in 1 BOTTLE | September 15, 2011 |
| 11822-0050-3 | 11822-0050 | Rite Aid Corporation | 1 BOTTLE in 1 CARTON (11822-0050-3) / 20 TABLET, FILM COATED in 1 BOTTLE | March 19, 2009 |
| 21130-623-76 | 21130-623 | Safeway | 1 BOTTLE in 1 CARTON (21130-623-76) / 120 TABLET, FILM COATED in 1 BOTTLE | December 29, 2025 |
| 0363-0050-27 | 0363-0050 | Walgreen Company | 1 BOTTLE in 1 CARTON (0363-0050-27) / 80 TABLET, FILM COATED in 1 BOTTLE | February 19, 2009 |
| 0363-0050-58 | 0363-0050 | Walgreen Company | 1 BOTTLE in 1 CARTON (0363-0050-58) / 40 TABLET, FILM COATED in 1 BOTTLE | July 12, 2013 |
| 0363-0050-60 | 0363-0050 | Walgreen Company | 1 BOTTLE in 1 CARTON (0363-0050-60) / 20 TABLET, FILM COATED in 1 BOTTLE | February 19, 2009 |
| 0363-0050-76 | 0363-0050 | Walgreen Company | 1 BOTTLE in 1 CARTON (0363-0050-76) / 120 TABLET, FILM COATED in 1 BOTTLE | January 7, 2016 |
| 0363-0050-82 | 0363-0050 | Walgreen Company | 200 TABLET, FILM COATED in 1 BOTTLE (0363-0050-82) | September 21, 2017 |
| 59779-050 | 59779-050 | CVS Pharmacy | — | February 17, 2009 |
| 37808-703 | 37808-703 | H E B | — | April 5, 2018 |
| 42507-050 | 42507-050 | HyVee Inc | — | March 2, 2009 |
| 30142-050 | 30142-050 | Kroger Company | — | April 6, 2009 |
| 41250-050 | 41250-050 | Meijer Distribution Inc | — | April 8, 2009 |
| 56062-050 | 56062-050 | Publix Super Markets Inc | — | September 15, 2011 |
| 11822-0050 | 11822-0050 | Rite Aid Corporation | — | March 19, 2009 |
| 21130-623 | 21130-623 | Safeway | — | December 29, 2025 |
| 0363-0050 | 0363-0050 | Walgreen Company | — | February 19, 2009 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 11 sections on this page.