Indications and uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
CVP 44-235
- Manufacturer
- Salado Sales, Inc. | LNK International, Inc.
- Effective date
- 2026-08-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 15
- Source
- daily-update
- Hydrated at
- 2026-08-20 01:01:50
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 adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours. children under 12 years: do not use
Storage and handling
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each caplet)
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 product containing diphenhydramine, even one used on skin
- in children under 12 years of age
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- liver disease
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- avoid alcoholic beverages
- drowsiness will occur
- 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 a 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.
In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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
- adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
- children under 12 years: do not use
Other information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive ingredients
colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue #1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide
Questions or comments?
1-800-426-9391
Principal Display Panel
CVP®
HEALTH
COMPARE TO EXTRA
STRENGTH TYLENOL® PM
ACTIVE INGREDIENTS*
EXTRA STRENGTH
PAIN
RELIEVER PM
ACETAMINOPHEN
DIPHENHYDRAMINE HCl
PAIN RELIEVER/
NIGHTTIME SLEEP AID
NON-ASPIRIN
ACTUAL
SIZE
50
CAPLETS
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0761706160220 | GTIN-13: 0761706160220 EAN-13: 0761706160220 GTIN-12: 761706160220 UPC-A: 761706160220 GTIN storage (14 digits): 00761706160220 | cvp-44-235-1.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 2 | |
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | 2 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 2 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 2 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | 2 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 2 |
Products#
Every source-derived product name is available through these pages.
- Pain Reliever PM Extra Strength
- Acetaminophen, Diphenhydramine HCl
- ACETAMINOPHEN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- SILICON DIOXIDE
- STARCH, CORN
- CROSCARMELLOSE SODIUM
- FD&C BLUE NO. 1 ALUMINUM LAKE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYVINYL ALCOHOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 57243-235 | 57243-235-15 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 14 | 2025-08-18 | full-release | 2026-06-01 01:11:00 |
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | TABLET, FILM COATED / ORAL | 20 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FILM COATED / ORAL | 91 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FILM COATED / ORAL | 91 mg | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | TABLET, FILM COATED / ORAL | 20 mg |
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 Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Salado Sales, Inc. | aef30709-f33d-48ff-b2d4-0639ffbd1ffd | 2026-08-07 | Warnings | 57243-235-15 57243-235 57243023515 ac1496d2-7b9e-468f-acdf-607a6efd98e8 aef30709-f33d-48ff-b2d4-0639ffbd1ffd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.