DR SIMI PAIN RELIEF- acetaminophen tablet, coated 
Farmacias De Similares TX LLC

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Pain reliever Acetaminophen 325 mg

Drug Facts

Active ingredient (in each caplet)

Purpose

Purpose

Pain reliever / Fever reducer

Uses

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:

Allergy alert: Acetaminophen may cause severe skin reactions.

Symptoms may include:

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

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 yearsAsk a doctor

Other information

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

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 85786-103-90

Regular Strength

Pain Reliever

Acetaminophen 325 mg

Pain Reliever/ Fever Reducer

100 Caplets

Aspirin Free

For Adults

PDP1

DF1

Tabla Drug facts 2 Acetaminophen 325

DR SIMI PAIN RELIEF 
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85786-103
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore2 pieces
ShapeCAPSULESize17mm
FlavorImprint Code S325
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:85786-103-90100 in 1 BOTTLE; Type 0: Not a Combination Product12/15/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01308/13/2025
Labeler - Farmacias De Similares TX LLC (119489934)
Establishment
NameAddressID/FEIBusiness Operations
Elysium Pharmacuticals Ltd863182240manufacture(85786-103) , analysis(85786-103) , label(85786-103) , pack(85786-103)

Revised: 8/2025
Document Id: 3c477d33-a8c3-d39f-e063-6294a90ac5f0
Set id: 3c477d33-a8c2-d39f-e063-6294a90ac5f0
Version: 1
Effective Time: 20250813
 
Farmacias De Similares TX LLC