DR SIMI PAIN RELIEF- acetaminophen tablet, coated

Dr Simi Pain Relief by

Drug Labeling and Warnings

Dr Simi Pain Relief 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 ingredient (in each caplet)

• Acetaminophen 325 mg

Purpose

Purpose

Pain reliever / Fever reducer

Uses

• Temporarily relieves minor aches and pains due to:
• Headache.
• Muscular aches.
• Backache.
• Minor pain of arthritis.
• The common cold.
• Toothache.
• Premenstrual and menstrual cramps.
• Temporarily reduces fever.

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg) in 24 hours for adults or 5 caplets (1,625 mg) in 24 hours for children. Severe liver damage may occur if:

• Adult takes more than 4,000 mg of acetaminophen in 24 hours.
• Child takes more than 5 doses in 24 hours, which is the maximum daily amount.
• Taken withother drugs containing acetaminophen.
• Adult has 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.
• if you are allergic to acetaminophen or any of the inactive ingredients in this product.
  

Ask a doctor before use if the user has

liver disease.

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin.

Stop use and ask doctor if

• Pain gets worse or lasts more than 10 days in adults.
• Pain gets worse or lasts more than 5 days in children under 12 years.
• Fever gets worse or lasts more than 3 days.
• New symptoms occur.
• Redness or swelling is present.

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

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).

Directions

• Adults and children 12 years and over:
  • Take 2 caplets every 4 to 6 hours while symptoms last.
  • Do not take more than 10 caplets in 24 hours, unless directed by a doctor.
  • Do not use for more than 10 days unless directed by a doctor.
• Children 6 years to under 12 years:
  • Take 1 caplet every 4 to 6 hours while symptoms last.
  • Do not take more than 5 caplets in 24 hours.
  • Do not use for more than 5 days unless directed by a doctor.
• Children under 6 years: Ask a doctor

Other information

• Store between 20-25°C (68-77°F).
• Read all product information before using.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

Hypromellose, Magnesium stearate, Microcrystalline Cellulose , Polyethylene glycol 400, Povidone, Pregelatinized Starch, Purified water, Stearic acid , Talc, 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#

EXP:

PEEL BACK for more DRUG FACTS

Principal display panel

DR SIMI

NDC: 85786-103-90

Regular Strength

Pain Reliever

Acetaminophen 325 mg

Pain Reliever/ Fever Reducer

100 Caplets

Aspirin Free

For Adults

INGREDIENTS AND APPEARANCE

DR SIMI PAIN RELIEF 
acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85786-103
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POVIDONE K30 (UNII: U725QWY32X)
TALC (UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
STARCH, CORN (UNII: O8232NY3SJ)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	S325
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85786-103-90	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	08/13/2025

Labeler - Farmacias De Similares TX LLC (119489934)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmacuticals Ltd		863182240	manufacture(85786-103) , analysis(85786-103) , label(85786-103) , pack(85786-103)