Active Ingredients And Purpose
Active ingredients (in each caplet)
Diphenhydramine hydrochloride 25 mg Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Purposes
Nighttime sleep-aid Pain reliever
topcare all night pain relief pm
- Manufacturer
- Topco Associates LLC
- Effective date
- 2025-12-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-06-01 01:22:19
Key Label Information#
Uses
Uses
• for relief of occasional sleeplessness when associated with minor aches and pains • helps you fall asleep and stay asleep
Warnings
Warnings
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Directions And Dosage
Directions
• do not take more than directed • drink a full glass of water with each dose • adults and children 12 years and over: take 2 caplets at bedtime • do not take more than 2 caplets in 24 hours • if taken with food, this product may take longer to work
Other Label Information
Other information
• read all warnings and directions before use. Keep outer carton. • each caplet contains: sodium 21 mg • store at 20-25°C (68-77°F) • avoid high humidity and excessive heat above 40°C (104°F)
Inactive ingredients
croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide
Questions or comments?
1-888-423-0139
Package/Label Principal Display Panel
TopCare ® health COMPARE TO ALEVE ® pm ACTIVE INGREDIENTS All Night Pain Relief PM NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE TABLETS, 220 mg / 25 mg PAIN RELIEVER (NSAID) • NIGHTTIME SLEEP-AID Sleep Aid Plus 12-Hour Pain Reliever actual size 20 CAPLETS† †CAPSULE-SHAPED TABLETS
Label Images#
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| NAPROXEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fef6ad89-235f-4274-ba49-a8e53642473e | Product name | 2 | 20250225 |
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 87fed3e6-8fba-48ef-96b0-3a7fb54b96ff | Product name | 3 | 20230306 |
| b5fdaaec-7251-4da6-9cb2-4e9e76939ec8 | Product name | 1 | 20200623 |
| e76dbbc1-775d-722c-08ff-ed45e8a80def | Product name | 3 | 20181002 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 6f4f4521-fd56-1ae6-888b-3b021bd75c7c | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| ce67e27d-1d21-5465-4409-b0662dd99d4d | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-264-27 | topcare all night pain relief pm | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 6 | |
| 36800-264-27 | topcare all night pain relief pm | 80 in 1 BOTTLE | TABLET, FILM COATED | 80 | 6 | |
| 36800-264-60 | topcare all night pain relief pm | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | 6 | |
| 36800-264-60 | topcare all night pain relief pm | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 6 |
Products#
- topcare all night pain relief pm
- diphenhydramine hydrochloride, naproxen sodium
- DIPHENHYDRAMINE
- NAPROXEN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 36800-264 | 36800-264-60, 36800-264-27 |
Ingredients#
Complete SPL Sections#
Active ingredients (in each caplet)
Diphenhydramine hydrochloride 25 mg Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Purposes
Nighttime sleep-aid Pain reliever
Uses
• for relief of occasional sleeplessness when associated with minor aches and pains • helps you fall asleep and stay asleep
Warnings
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Directions
• do not take more than directed • drink a full glass of water with each dose • adults and children 12 years and over: take 2 caplets at bedtime • do not take more than 2 caplets in 24 hours • if taken with food, this product may take longer to work
Other information
• read all warnings and directions before use. Keep outer carton. • each caplet contains: sodium 21 mg • store at 20-25°C (68-77°F) • avoid high humidity and excessive heat above 40°C (104°F)
Inactive ingredients
croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide
Questions or comments?
1-888-423-0139
Package/Label Principal Display Panel
TopCare ® health COMPARE TO ALEVE ® pm ACTIVE INGREDIENTS All Night Pain Relief PM NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE TABLETS, 220 mg / 25 mg PAIN RELIEVER (NSAID) • NIGHTTIME SLEEP-AID Sleep Aid Plus 12-Hour Pain Reliever actual size 20 CAPLETS† †CAPSULE-SHAPED TABLETS