Indications and uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Pain Reliever PM
- Manufacturer
- McKesson (Sunmark)
- Effective date
- 2019-04-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:26:35
Label at a glance#
ProductPain Reliever PM extra strength
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 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 at room temperature 15º-30ºC (59º-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
Do not use
- with other products 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
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 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 at room temperature 15º-30ºC (59º-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
*contains one or more of these ingredients
Questions or comments?
Call toll free: 1-877-753-3935 Monday-Friday 9AM-5PM EST
PRINCIPAL DISPLAY PANEL
COMPARE TO EXTRA STRENGTH TYLENOL® PM ACTIVE INGREDIENTS**
Pain Reliever PM
Extra Strength
Pain reliever & Nighttime sleep-aid
ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HCl 25 mg
GELTABS
**This prodcut is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® PM.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Product Label
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0010939428332 | GTIN-13: 0010939428332 EAN-13: 0010939428332 GTIN-12: 010939428332 UPC-A: 010939428332 GTIN storage (14 digits): 00010939428332 | acetaminophen-pm-geltabs-delisted-1.jpg |
| Data code | ITF | 02906881 | acetaminophen-pm-geltabs-delisted-1.jpg |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49348-292-09 | EA - Each | 49348-292 | 49c39351-0979-4d4c-bb82-c7f65c3ab107 | 1 | 2019-04-11 |
Products#
Every source-derived product name is available through these pages.
- Pain Reliever PM extra strength
- 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
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49348-292 | 49348-292-09 |
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 |
|---|---|---|---|---|---|---|
| 1bfda7e9-3764-4b00-9195-1d8a8d0a1d27 | 8e96d08c-22aa-4d08-a226-3e25fb1f20bd | 2019-04-09 | Warnings | 1bfda7e9-3764-4b00-9195-1d8a8d0a1d27 8e96d08c-22aa-4d08-a226-3e25fb1f20bd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.