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 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 this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
(in each caplet)
Acetaminophen, USP 500 mg
Diphenhydramine HCl 25 mg
Pain reliever
Nighttime sleep aid
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
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
■ 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
■ 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 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.
ask a health professional before use.
Taking more than the recommended dose (overdose) may cause liver damage. 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 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 this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
■ store between 20°-25°C (68°-77°F)
■ do not use if carton is opened, or neck wrap or foil inner seal broken or mising
■ see end panel for lot number and expiration date
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, pregelatinized starch, polysorbate 80, polyethylene glycol 400, povidone, stearic acid, titanium dioxide
call 1-844-724-7347 Mon-Fri 9:00 AM to 4:30 PM EST
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68016-654-05 | Acetaminophen Diphenhydramine HCl | 50 in 1 BOTTLE | TABLET | 50 | 1 | |
| 68016-654-10 | Acetaminophen Diphenhydramine HCl | 100 in 1 BOTTLE | TABLET | 100 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68016-654-05 | EA - Each | 68016-654 | be20fe90-133d-4e03-8ec0-79849d654f3c | 1 | 2022-06-06 |
| 68016-654-10 | EA - Each | 68016-654 | 25339739-b021-4a1d-801e-4e3de1a4f12e | 1 | 2022-06-06 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68016-654 | 68016-654-05, 68016-654-10 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DIPHENHYDRAMINE | 8GTS82S83M | ACTIB |
| STARCH, PREGELATINIZED CORN | O8232NY3SJ | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POVIDONE | FZ989GH94E | IACT |
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 |
|---|---|---|---|---|---|---|
| Acetaminophen Diphenhydramine HCl | ACETAMINOPHEN DIPHENHYDRAMINE HCL | Chain Drug Consortium,LLC | 47f839b9-ac8a-161c-e054-00144ff8d46c | 2017-02-07 | Warnings | 68016-654-05 68016-654-10 68016-654 68016065405 68016065410 47f839b9-ac8b-161c-e054-00144ff8d46c 47f839b9-ac8a-161c-e054-00144ff8d46c |
Adverse event summaries are temporarily unavailable. Other product information remains available.