DR. SIMI PAIN RELIEVER PM- acetaminophen, diphenhydramine hcl tablet

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts Active ingredients (in each caplet)

Acetaminophen 500 mg
Diphenhydramine HCl 25 mg

Purpose

• Acetaminophen 500 mg: Pain reliever
• Diphenhydramine HCl 25 mg:

  Nighttime sleep aid

Uses

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

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 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

■ 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

■ 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 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.

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 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

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

Inactive ingredients

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?

855-280-1079

Principal Display Panel

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

INGREDIENTS AND APPEARANCE

DR. SIMI PAIN RELIEVER PM 
acetaminophen, diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85786-108
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HCL (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HCL	25 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	AAA;1031
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85786-108-24	1 in 1 CARTON	04/10/2026
1		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	04/10/2026

Labeler - Farmacias De Similares TX LLC (119489934)

Establishment
Name	Address	ID/FEI	Business Operations
AAA Pharmaceutical, Inc.		080164679	manufacture(85786-108)

Establishment
Name	Address	ID/FEI	Business Operations
AAA Pharmaceutical, Inc.		181192162	pack(85786-108)