Indications and uses
for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Unisom PM Pain Nighttime Sleep Aid and Pain Reliever
- Manufacturer
- Chattem, Inc.
- Effective date
- 2026-01-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 9
- Source
- full-release
- Hydrated at
- 2026-06-01 01:32:32
Label at a glance#
ProductUnisom PM Pain Nighttime Sleep Aid and Pain Reliever
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
• do not take more than directed (see overdose warning ) adults and children 12 years and older: • take 1 caplet at bedtime • do not take more than 1 caplet 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
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredients
(in each caplet)
Acetaminophen 325 mg
Purposes
Pain reliever
Active ingredients
(in each caplet)
Diphenhydramine HCl 50 mg
Purposes
Nighttime sleep-aid
Uses
- for the 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
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.
- in children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
- 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 medical illness.
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for 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:
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. 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 older: • take 1 caplet at bedtime
• do not take more than 1 caplet 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
Inactive ingredients
blue 1 lake, croscarmellose sodium, dicalcium phosphate, hydroxypropylcellulose, hypromellose, magnesium silicate, magnesium stearate, microcrystalline cellulose, mineral oil, pregelatinized corn starch, PVP, silica, sodium carboxymethyl starch, stearic acid (283-056)
PRINCIPAL DISPLAY PANEL
Unisom®
PM PAIN
SLEEPCAPSTM
30 Caplets
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1093075 | acetaminophen 325 MG / diphenhydrAMINE HCl 50 MG Oral Tablet | PSN | 9 |
| 1093077 | Unisom PM Pain SleepCaps 325 MG / 50 MG Oral Tablet | PSN | 9 |
| 1093077 | acetaminophen 325 MG / diphenhydramine hydrochloride 50 MG Oral Tablet [Unisom with Pain Relief] | SBD | 9 |
| 1093075 | acetaminophen 325 MG / diphenhydramine hydrochloride 50 MG Oral Tablet | SCD | 9 |
| 1093075 | APAP 325 MG / diphenhydramine hydrochloride 50 MG Oral Tablet | SY | 9 |
| 1093077 | APAP 325 MG / Diphenhydramine Hydrochloride 50 MG Oral Tablet [Unisom with Pain Relief] | SY | 9 |
| 1093077 | Unisom with Pain Relief (APAP 325 MG / diphenhydramine hydrochloride 50 MG) Oral Tablet | SY | 9 |
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 |
|---|---|---|---|---|---|---|
| 41167-0040-2 | Unisom PM Pain Nighttime Sleep Aid and Pain Reliever | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 9 | |
| 41167-0040-2 | Unisom PM Pain Nighttime Sleep Aid and Pain Reliever | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | 9 | |
| 41167-0040-3 | Unisom PM Pain Nighttime Sleep Aid and Pain Reliever | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 9 | |
| 41167-0040-3 | Unisom PM Pain Nighttime Sleep Aid and Pain Reliever | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | 9 | |
| 41167-0040-4 | Unisom PM Pain Nighttime Sleep Aid and Pain Reliever | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 9 | |
| 41167-0040-4 | Unisom PM Pain Nighttime Sleep Aid and Pain Reliever | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 9 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | 1 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | 1 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| MAGNESIUM SILICATE | INACTIVE INGREDIENT | 9B9691B2N9 | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 |
Products#
Every source-derived product name is available through these pages.
- Unisom PM Pain Nighttime Sleep Aid and Pain Reliever
- Acetaminophen and Diphenhydramine Hydrochloride
- ACETAMINOPHEN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- FD&C BLUE NO. 1
- CROSCARMELLOSE SODIUM
- DIBASIC CALCIUM PHOSPHATE DIHYDRATE
- HYDROXYPROPYL CELLULOSE, UNSPECIFIED
- HYPROMELLOSES
- MAGNESIUM SILICATE
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- LIGHT MINERAL OIL
- STARCH, CORN
- POVIDONE K30
- SILICON DIOXIDE
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 41167-0040 | 41167-0040-2, 41167-0040-3, 41167-0040-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| HYPROMELLOSE | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, FILM COATED / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| HYDROXYPROPYL CELLULOSE | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, FILM COATED / ORAL | 131.67 mg | ||
| HYDROXYPROPYL CELLULOSE | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, FILM COATED / ORAL | 131.67 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| HYDROXYPROPYL CELLULOSE | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, FILM COATED / ORAL | 131.67 mg | ||
| HYPROMELLOSE | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| MAGNESIUM SILICATE | MAGNESIUM SILICATE | 9B9691B2N9 | TABLET, FILM COATED / ORAL | 33.7 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg | ||
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | TABLET, FILM COATED / ORAL | 1075 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, FILM COATED / ORAL | NA | ||
| HYPROMELLOSE | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| HYDROXYPROPYL CELLULOSE | HYDROXYPROPYL CELLULOSE (1600000 WAMW) | RFW2ET671P | TABLET, FILM COATED / ORAL | 131.67 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | TABLET, FILM COATED / ORAL | 1075 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | TABLET, FILM COATED / ORAL | 1075 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| MAGNESIUM SILICATE | MAGNESIUM SILICATE | 9B9691B2N9 | TABLET, FILM COATED / ORAL | 33.7 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, FILM COATED / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg | ||
| HYPROMELLOSE | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | TABLET, FILM COATED / ORAL | 1075 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| MAGNESIUM SILICATE | MAGNESIUM SILICATE | 9B9691B2N9 | TABLET, FILM COATED / ORAL | 33.7 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| MAGNESIUM SILICATE | MAGNESIUM SILICATE | 9B9691B2N9 | TABLET, FILM COATED / ORAL | 33.7 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, FILM COATED / ORAL | NA |
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 |
|---|---|---|---|---|---|---|
| Unisom PM Pain Nighttime Sleep Aid and Pain Reliever | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Chattem, Inc. | 451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb | 2026-01-14 | Warnings | 41167-0040-3 41167-0040-4 41167-0040-2 41167-0040 41167004004 41167004002 41167004003 75e0be81-2c6a-461a-9da5-c2aa060e2dc8 451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.