Indications and uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.
Pain Reliever PM
- Manufacturer
- QUALITY CHOICE (Chain Drug Marketing Association)
- Effective date
- 2025-02-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:55:32
Label at a glance#
ProductPain Reliever PM
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 geltabs at bedtime. Do not take more than 2 geltabs of this product in 24 hours. children under 12 years: do not use
Storage and handling
store between 20-25ºC (68-86ºF) avoid high humidity and excessive heat
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each geltab)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Purpose
Pain reliever
Nighttime sleep-aid
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- with any other product containing diphenhydramine, even one used on skin
- in children under 12 years of age
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- glaucoma
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- drowsiness will occur
- avoid alcoholic drinks
- do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away: Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see overdose warning)
- adults and children 12 years and over: take 2 geltabs at bedtime. Do not take more than 2 geltabs of this product in 24 hours.
- children under 12 years: do not use
Other information
- store between 20-25ºC (68-86ºF)
- avoid high humidity and excessive heat
Inactive ingredients
corn starch, croscarmellose sodium, D&C red #27 aluminum lake, edible black ink, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, purified water, silicon dioxide, stearic acid, titanium dioxide
Questions or comments?
Call1-800-935-2362 Monday-Friday 9AM-5PM EST
Principal Display Panel
*Compare to the Active Ingredient in Extra Strength TYLENOL® PM
Extra Strength
Pain Reliever PM
Pain Reliever | Nighttime Sleep-Aid
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Geltabs
*This product is not manufactured or distributed by Kenvue Brands LLC., distributor of Extra Strength Tylenol® PM.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by CDMA, Inc.
Novi MI 48375
Product Label
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83324-166-50 | Pain Reliever PM | 1 in 1 BOX | TABLET, COATED | 1 | 3 | |
| 83324-166-50 | Pain Reliever PM | 50 in 1 BOTTLE, PLASTIC | TABLET, COATED | 50 | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 83324-166-50 | EA - Each | 83324-166 | d7807ebb-8ad4-4d0c-a2d3-af3100a43234 | 1 | 2025-05-14 |
Products#
Every source-derived product name is available through these pages.
- Pain Reliever PM
- Acetaminophen Diphenhydramine HCl
- ACETAMINOPHEN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- STARCH, CORN
- D&C RED NO. 27
- FD&C BLUE NO. 1
- GELATIN
- GLYCERIN
- HYPROMELLOSES
- MALTODEXTRIN
- CELLULOSE, MICROCRYSTALLINE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- WATER
- SILICON DIOXIDE
- STEARIC ACID
- TITANIUM DIOXIDE
- CROSCARMELLOSE SODIUM
- ALUMINUM OXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 83324-166 | 83324-166-50 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Pain Reliever PM | ACETAMINOPHEN DIPHENHYDRAMINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 4897d1df-4fb3-46e2-bbf0-847e964dca0a | 2025-02-18 | Warnings | 83324-166-50 83324-166 83324016650 c4f72afc-beca-430d-8b84-ed468208a7b6 4897d1df-4fb3-46e2-bbf0-847e964dca0a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.