Indications and uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
- Manufacturer
- Cabinet Health P.B.C.
- Effective date
- 2024-10-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:31:28
Label at a glance#
ProductValuMeds Pain Relief PM Pain Reliever and Nighttime Sleep Aid Acetaminophen, Extra Strength
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 sections
Dosage and administration
do not take more than directed (see overdose warning) 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
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each caplet)
Acetaminophen USP, 500 mg
Diphenhydramine HCl USP, 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.
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
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. (1-800-222-1222) 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 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 between 20°-25°C (68°-77°F)
- see bottom of the label for expiration date and lot number
Inactive ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k-30, pregelatinized starch, stearic acid, titanium dioxide
Questions or comments?
contact 1-908-242-6108 Mon- Fri 8:00 AM EST to 5:00 PM PST
Package Labeling:
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 |
|---|---|---|---|---|---|---|
| 82725-1024-1 | ValuMeds Pain Relief PM Pain Reliever and Nighttime Sleep Aid Acetaminophen, Extra Strength | 375 in 1 BOTTLE | TABLET | 375 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 82725-1024 | VALUMEDS PAIN RELIEF PM PAIN RELIEVER AND NIGHTTIME SLEEP AID ACETAMINOPHEN, EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CABINET HEALTH P.B.C.] | 1 | Current NDC, 1 package rows | 20241031_19ba1fb6-22ea-488e-9e52-94c14ceb80d1.zip |
Products#
Every source-derived product name is available through these pages.
- ValuMeds Pain Relief PM Pain Reliever and Nighttime Sleep Aid Acetaminophen, Extra Strength
- ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
- CARNAUBA WAX
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- FD&C BLUE NO. 1 ALUMINUM LAKE
- FD&C BLUE NO. 2 ALUMINUM LAKE
- HYPROMELLOSE, UNSPECIFIED
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYSORBATE 80
- POVIDONE K30
- STEARIC ACID
- TITANIUM DIOXIDE
- ACETAMINOPHEN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82725-1024 | 82725-1024-1 |
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 |
|---|---|---|---|---|---|---|
| ValuMeds Pain Relief PM Pain Reliever and Nighttime Sleep Aid Acetaminophen, Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | 19ba1fb6-22ea-488e-9e52-94c14ceb80d1 | 2024-10-07 | Warnings | 82725-1024-1 82725-1024 82725102401 23e600aa-9720-e2be-e063-6294a90a6914 19ba1fb6-22ea-488e-9e52-94c14ceb80d1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.