DR SIMI PAIN RELIEVER PM- acetaminophen, diphenhydramine hydrochloride tablet, coated

Dr Simi Pain Reliever PM by

Drug Labeling and Warnings

Dr Simi Pain Reliever PM by is a Otc medication manufactured, distributed, or labeled by Farmacias De Similares TX LLC, Elysium Pharmacuticals Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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:
  • 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 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

www.drsimi.com

LOT:

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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

INGREDIENTS AND APPEARANCE

DR SIMI PAIN RELIEVER PM 
acetaminophen, diphenhydramine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85786-101
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
STARCH, CORN (UNII: O8232NY3SJ)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE K30 (UNII: U725QWY32X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	APM
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85786-101-90	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/15/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	08/11/2025

Labeler - Farmacias De Similares TX LLC (119489934)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmacuticals Ltd		863182240	manufacture(85786-101) , analysis(85786-101) , pack(85786-101) , label(85786-101)