Dosage and administration
do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 caplets at bedtime if needed do not take more than directed children under 12 years: do not use
do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 caplets at bedtime if needed do not take more than directed children under 12 years: do not use
store at room temperature 15º-30ºC (59º-86ºF)
Drug Facts
Acetaminophen 500 mg
Diphenhydramine HCL 25 mg
Pain reliever
Nighttime sleep aid
temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
Ask a doctor before use if you have
Drug Facts continued on back of label
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask a doctor if
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: Taking more than the recommended dose (overdose) may cause liver damage. Incase of 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 signs or symptoms.
adults and children 12 years and over:
children under 12 years: do not use
store at room temperature 15º-30ºC (59º-86ºF)
croscarmellose sodium, FD&C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol 400, povidone, pregelatinized corn starch, silicon dioxide, stearic acid, titanium dioxide
call 516-341-0666, 8:30 am- 4:30 pm ET, Monday-Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Tylenol® PM
Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580
NDC 69618-013-05
Acetaminophen 500 mg & Diphenhydramine HCL 25 mg
PAIN RELIEVER
NIGHTTIME SLEEP AID
50 CAPLETS
*Compare to Active Ingredients in Tylenol® PM
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69618-013-05 | 2021-08-09 | C162847 | 48780-1 | 9d75b9cf-fcce-f424-e053-dadaa90a57ce | ACETAMINOPHEN / DIPHENHYDRAMINE 500/25 MG CAPLET |
| 69618-013-05 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-fcce-f424-e053-dadaa90a57ce | ACETAMINOPHEN / DIPHENHYDRAMINE 500/25 MG CAPLET |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69618-013-05 | EA - Each | 69618-013 | f7c92036-33ce-4ffc-92e5-4c24c6666869 | 1 | 2016-01-13 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69618-013 | 69618-013-05 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| c927a1d1-5038-9c42-e053-2a95a90ad495 | 26f5fdd4-d841-2e12-e054-00144ff88e88 | 2021-08-09 | Warnings | 26f5fdd4-d841-2e12-e054-00144ff88e88 |
Adverse event summaries are temporarily unavailable. Other product information remains available.