Active Ingredients And Purpose
Active ingredients (in each caplet)
Acetaminophen 500 mg Diphenhydramine HCl 25 mg
Purpose
Pain reliever Nighttime sleep aid
Extra Sterength Pain Relief PM
- Set ID
- 3a782f3a-1c84-4268-81a7-d0b999914fdd
- Manufacturer
- SPIRIT PHARMACEUTICALS LLC
- Effective date
- 2024-12-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:43:08
Key Label Information
Uses
Uses
For the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings
WARNINGS SECTION
Warnings
Directions And Dosage
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 this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
Other Label Information
Other information
each caplet contains: magnesium 0.05 mg store between 20°-25°C (68°-77°F)
Inactive ingredients
FD&C blue # 1, FD&C blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol-400, povidone k-30, pregelatinized starch, purified water, stearic acid, titanium dioxide
Questions or comments?
1-888-333-9792
PRINCIPAL DISPLAY PANEL
Extra Strength Pain relief PM Acetaminophen 500 mg - Pain Reliever Diphenhydramine 25 mg - Nighttime Sleep-Aid Non-habit forming 24 Softgels
Products
- EXTRA STRENGTH PAIN RELIEF PM
- ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
NDC Codes
Ingredients
| 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 400 | B697894SGQ | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| STARCH, PREGELATINIZED CORN | O8232NY3SJ | IACT |
| WATER | 059QF0KO0R | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
Complete SPL Sections
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredients (in each caplet)
Acetaminophen 500 mg Diphenhydramine HCl 25 mg
Purpose
Pain reliever Nighttime sleep aid
Uses
For the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
WARNINGS SECTION
Warnings
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 this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
Other information
each caplet contains: magnesium 0.05 mg store between 20°-25°C (68°-77°F)
Inactive ingredients
FD&C blue # 1, FD&C blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol-400, povidone k-30, pregelatinized starch, purified water, stearic acid, titanium dioxide
Questions or comments?
1-888-333-9792
PRINCIPAL DISPLAY PANEL
Extra Strength Pain relief PM Acetaminophen 500 mg - Pain Reliever Diphenhydramine 25 mg - Nighttime Sleep-Aid Non-habit forming 24 Softgels
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
- dailymed/3a782f3a-1c84-4268-81a7-d0b999914fdd/292e509a-6b35-3c0b-e063-6294a90a97c1.xml
- XML SHA-256
- 802e2314171b8fafc2d31caf1207df092f4d19f3093e5f702695cef3de378bf8
- XML bytes
- 32237
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 292e509a-6b35-3c0b-e063-6294a90a97c1.xml | 2024-12-15 |
| otc | 0bf321f6-af55-2482-e063-6394a90aa1cc.xml | 2023-12-08 |
| otc | ee8f02d1-fbcd-ab46-e053-2a95a90ae3ab.xml | 2022-11-30 |
| otc | cfd45204-414b-fefc-e053-2a95a90ad68f.xml | 2021-11-03 |
| otc | Pain Relief ES 24 ct.jpg | 2021-11-03 |
| otc | c10c5f5c-fd25-1d60-e053-2a95a90a3d6a.xml | 2021-04-29 |
| otc | ES PAIN RELIEF PM, 24 CT.jpg | 2021-04-29 |