Indications and uses
Temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness.
Dr Simi Pain Reliever PM
- Manufacturer
- Farmacias De Similares TX LLC | Elysium Pharmacuticals Ltd
- Effective date
- 2025-08-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:33:51
Label at a glance#
ProductDr Simi Pain Reliever PM
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
Do not use 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
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
Active ingredients (in each caplet)
- Acetaminophen 500 mg
- Diphenhydramine HCl 25 mg
Pupose
- Pain reliever
- Nighttime sleep aid
Uses
Temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness.
Warnings
Warnings
WARNINGS SECTION
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take.
- More than 2 caplets in 24 hours, which is the maximum daily amount for this product.
- With other drugs containing acetaminophen.
- 3 or more alcoholicdrinks everyday while using this product.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- Skin reddening
- Blisters
- Rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- With any other drug containing acetaminophen (prescription or not prescription). 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.
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 your doctor or pharmacist before use if you are
- Taking the blood thinning drug warfarin
- Taking sedative 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 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.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
Keep out of reach of children.
Overdose warning:
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.
Directions
- Do not use more than directed (see overdose warning).
Directions
| Adults and children 12 years and over |
|
| Children under 12 years | Do not use |
Other information
- Store at 25 °C (77°F) excursions permitted between 15-30°C (59-86°F)
- Read all product information before using.
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Inactive ingredients
FD&C Blue No. 1, FD&C Blue No. 2, Hypromellose, Magnesium stearate, Microcrystalline cellulose, Polyethylene glycol, Povidone, Pregelatinized starch, Purified water, Stearic Acid, Titanium dioxide.
Questions or comments?
(855)-280-1079
SPL UNCLASSIFIED SECTION
Distributed by: FARMACIAS DE SIMILARES TX, LLC
800 Brazos St Ste 260, Austin, TX,
78701, USA.
customerservice@drsimi.com
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DR SIMI
NDC 85786-101-90
Extra Strength
Pain Reliver PM
Acetaminophen 500 mg
Pain Reliever
Diphenhydramine HCl 25 mg
Nightime Sleep Aid
100 Caplets
Aspirin Free
Non-Habit Forming
For Adults
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0850070048811 | GTIN-13: 0850070048811 EAN-13: 0850070048811 GTIN-12: 850070048811 UPC-A: 850070048811 GTIN storage (14 digits): 00850070048811 | Principal Display Panel Pain Relief AcDip.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85786-101-90 | Dr Simi Pain Reliever PM | 100 in 1 BOTTLE | TABLET, COATED | 100 | 1 |
Products#
Every source-derived product name is available through these pages.
- Dr Simi Pain Reliever PM
- Acetaminophen, Diphenhydramine Hydrochloride
- FD&C BLUE NO. 1
- STARCH, CORN
- WATER
- ACETAMINOPHEN
- FD&C BLUE NO. 2
- STEARIC ACID
- HYPROMELLOSE, UNSPECIFIED
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- MAGNESIUM STEARATE
- POVIDONE K30
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85786-101 | 85786-101-90 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 |
|---|---|---|---|---|---|---|
| Dr Simi Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Farmacias De Similares TX LLC | 3c19ad99-6e0f-3116-e063-6394a90a914c | 2025-08-11 | Warnings | 85786-101-90 85786-101 85786010190 3c19ad99-6e10-3116-e063-6394a90a914c 3c19ad99-6e0f-3116-e063-6394a90a914c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.