FDA.reportPublic FDA data

Dr. Simi Pain Reliever PM

Manufacturer
Farmacias De Similares TX LLC | AAA Pharmaceutical, Inc.
Effective date
2026-04-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:53:40

Label at a glance#

ProductDr. Simi Pain Reliever PM
Active ingredientDIPHENHYDRAMINE HCL, ACETAMINOPHEN
Label structure10 sections

Indications and uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Dosage and administration

■ 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

Label contents#

Full prescribing information#

Drug Facts Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg
Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Acetaminophen 500 mgPain reliever

Diphenhydramine HCl 25 mg

Nighttime sleep aid

Uses

INDICATIONS & USAGE SECTION

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings

WARNINGS SECTION

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

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

OTC - DO NOT USE SECTION

■ with any other drug containing acetaminophen (prescription or nonprescription). 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

OTC - ASK DOCTOR SECTION

■ liver disease
■ glaucoma
■ a breathing problem such as emphysema or chronic bronchitis
■ trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

■ drowsiness will occur
■ avoid alcoholic drinks
■ do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

■ 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

Other information

OTHER SAFETY INFORMATION

■ store between 20-25°C (68-77°F) in a dry place
■ retain carton for complete product information

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

855-280-1079

Principal Display Panel

SPL UNCLASSIFIED SECTION

NDC: 85786-108-24

DR. SIMI

Extra strength

Pain Reliever PM

Acetaminophen 500 mg
Diphenhydramine HCl 25 mg

Pain Reliever / Nighttime Sleep Aid

For Adults

24 Caplets

†Compare to the active ingredients in Tylenol® PM Extra Strength Caplets

†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® PM Extra Strength Caplets.

DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROJEN OR MISSING

Distributed by:
FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA
customerservice@drsimi.com
www.drsimi.com

Carton labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton labelingCarton labeling

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN1
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD1
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85786-108-24Dr. Simi Pain Reliever PM24 in 1 BOTTLE, PLASTICTABLET241
85786-108-24Dr. Simi Pain Reliever PM1 in 1 CARTONTABLET11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85786-10885786-108-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
STEARIC ACID4ELV7Z65APIACT
DIPHENHYDRAMINE HCLTC2D6JAD40ACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
ACETAMINOPHEN362O9ITL9DACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
COPOVIDONE K25-31D9C330MD8BIACT
POVIDONEFZ989GH94EIACT

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Simi Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLFarmacias De Similares TX LLC4f1e1f1a-44f4-2356-e063-6294a90a8cdd2026-04-10WarningsExact identifier
ndc (package): 85786-108-24
ndc (product): 85786-108
ndc11 (package): 85786010824
spl id: 4f1e1f1a-44f5-2356-e063-6294a90a8cdd
spl set id: 4f1e1f1a-44f4-2356-e063-6294a90a8cdd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.