Indications and uses
• temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
• temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
do not take more than directed (see overdose warning) adults & children 12 years & over • take 2 tablets at bedtime • do not take more than 2 tablets of this product in 24 hours children under 12 years do not use
• store between 20–25°C (68–77°F)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Pain reliever
Nighttime sleep aid
• temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
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.
• with 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
• liver disease • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland • glaucoma
• taking the blood thinning drug warfarin • taking sedatives or tranquilizers
• drowsiness will occur • avoid alcoholic drinks • do not drive a motor vehicle or operate machinery
• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness • pain gets worse or lasts for 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.
ask a health professional before use.
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.
do not take more than directed (see overdose warning)
| adults & children 12 years & over | • take 2 tablets at bedtime
• do not take more than 2 tablets of this product in 24 hours |
| children under 12 years | do not use |
• store between 20–25°C (68–77°F)
FD&C Blue No. 1, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide
1-888-333-9792
Cabinet Health P.B.C.
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| 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 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68210-4226-1 | Pain Reliever and Sleep Aid | 120 in 1 JAR | TABLET, FILM COATED | 120 | 4 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68210-4226 | PAIN RELIEVER AND SLEEP AID (ACETAMINOPHEN, AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC] | 4 | Legacy NDC, 1 package rows | 20241215_9143ff6a-b044-4e76-8a23-cf684a60d8bc.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68210-4226 | 68210-4226-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C BLUE NO. 2 | L06K8R7DQK | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 2915ac4c-fd7d-1e43-e063-6394a90a9253 | 9143ff6a-b044-4e76-8a23-cf684a60d8bc | 2024-12-12 | Warnings | 2915ac4c-fd7d-1e43-e063-6394a90a9253 9143ff6a-b044-4e76-8a23-cf684a60d8bc |
Adverse event summaries are temporarily unavailable. Other product information remains available.