pain relief pm
Acetaminophen PM · Tablet, Coated · Oral
Active ingredient
Active ingredients (in each capsule) Diphenhydramine hydrochloride 25 mg Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug
Purpose
Purposes Nighttime sleep-aid Pain reliever
Uses
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 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 delivery 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.
Do not use
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
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
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
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
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
Pregnancy or breast-feeding
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 delivery problems in the unborn child or complications during delivery.
Keep out of reach of children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
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
Other information ■ each capsule contains: potassium 20 mg ■ read all warnings and directions before use. Keep carton. ■ store at 20° to 25°C (68° to 77°F) ■ avoid excessive heat above 40°C (104°F) ■ protect from light
Inactive ingredients
Inactive ingredients gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol
Questions?
Questions? call toll-free 1-888-235-2466
Label text from the FDA structured product label by Bionpharma Inc. (revised May 4, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Diphenhydramine Hydrochloride in 27 products
- Acetaminophen in 26 products
- Ibuprofen in 2 products
- Aspirin in 1 product
- Diphenhydramine Citrate in 1 product
pain relief pm NDC products (28)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 69452-264 | Ibuprofen 200 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Capsule, Liquid Filled | Bionpharma Inc. | ANDA |
| 69452-507 | Ibuprofen 200 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Capsule, Liquid Filled | Bionpharma Inc. | ANDA |
| 69168-393 | Acetaminophen 500 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Tablet | Allegiant Health | OTC MONOGRAPH DRUG |
| 69168-003 | Acetaminophen 500 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Tablet | Allegiant Health | OTC MONOGRAPH DRUG |
| 61504-095 | Acetaminophen 500 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Tablet, Coated | AMERIFOODS TRADING COMPANY | OTC MONOGRAPH DRUG |
| 63868-325 | Acetaminophen 500 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Tablet, Coated | Chain Drug Marketing Association | OTC MONOGRAPH DRUG |
| 83324-085 | Acetaminophen 500 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Tablet, Coated | CHAIN DRUG MARKETING ASSOCIATION, INC. | OTC MONOGRAPH DRUG |
| 59779-894 | Acetaminophen 250 mg/1; Aspirin 250 mg/1; Diphenhydramine Citrate 38 mg/1 Tablet, Film Coated | CVS Pharmacy | OTC MONOGRAPH DRUG |
| 55910-834 | Acetaminophen 500 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Tablet | DOLGENCORP, INC. | OTC MONOGRAPH DRUG |
| 55910-655 | Acetaminophen 500 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Tablet, Coated | DOLGENCORP, LLC | OTC MONOGRAPH DRUG |
| 50804-825 | Acetaminophen 500 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Tablet, Coated | GoodSense | OTC MONOGRAPH DRUG |
| 37808-556 | Acetaminophen 500 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Tablet, Coated | H E B | OTC MONOGRAPH DRUG |
| 72036-095 | Acetaminophen 500 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Tablet, Coated | HARRIS TEETER | OTC MONOGRAPH DRUG |
| 37808-795 | Acetaminophen 500 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Tablet, Coated | HEB | OTC MONOGRAPH DRUG |
| 42507-095 | Acetaminophen 500 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Tablet, Coated | HYVEE INC | OTC MONOGRAPH DRUG |
| 68998-071 | Acetaminophen 500 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Tablet, Coated | MARC GLASSMAN, INC. | OTC MONOGRAPH DRUG |
| 68998-195 | Acetaminophen 500 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Tablet, Coated | MARC GLASSMAN, INC. | OTC MONOGRAPH DRUG |
| 41250-195 | Acetaminophen 500 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Tablet, Coated | Meijer | OTC MONOGRAPH DRUG |
| 84324-005 | Diphenhydramine Hydrochloride 25 mg/1; Acetaminophen 500 mg/1 Tablet | NUVICARE LLC | OTC MONOGRAPH DRUG |
| 72090-006 | Diphenhydramine Hydrochloride 25 mg/1; Acetaminophen 500 mg/1 Tablet | Pioneer Life Sciences, LLC | OTC MONOGRAPH DRUG |
| 72090-032 | Diphenhydramine Hydrochloride 25 mg/1; Acetaminophen 500 mg/1 Tablet | Pioneer Life Sciences, LLC | OTC MONOGRAPH DRUG |
| 56062-437 | Acetaminophen 500 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Tablet, Film Coated | Publix Super Markets Inc | OTC MONOGRAPH DRUG |
| 63868-119 | Acetaminophen 500 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Tablet, Coated | QUALITY CHOICE (Chain Drug Marketing Association) | OTC MONOGRAPH DRUG |
| 21130-095 | Acetaminophen 500 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Tablet, Coated | Safeway | OTC MONOGRAPH DRUG |
| 70677-0081 | Acetaminophen 500 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Tablet, Coated | Strategic Sourcing Services LLC | OTC MONOGRAPH DRUG |
| 36800-095 | Acetaminophen 500 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Tablet, Coated | TopCo Associates LLC | OTC MONOGRAPH DRUG |
| 36800-556 | Acetaminophen 500 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Tablet, Coated | Topco Associates, LLC | OTC MONOGRAPH DRUG |
| 76168-119 | Acetaminophen 500 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Tablet | Velocity Pharma | OTC MONOGRAPH NOT FINAL |
Frequently asked questions
What is pain relief 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 pain relief pm?
pain relief pm is listed by 24 labelers in the FDA NDC directory, including Bionpharma Inc., Allegiant Health, AMERIFOODS TRADING COMPANY, Chain Drug Marketing Association.