DR SIMI PAIN RELIEF 100- acetaminophen tablet, coated

Dr Simi Pain Relief 100 by

Drug Labeling and Warnings

Dr Simi Pain Relief 100 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): Purpose
• Acetaminophen 500 mg: Pain reliever / Fever reducer

Purpose

• Active ingredient (in each caplet): Purpose
• Acetaminophen 500 mg:

  Pain reliever/Fever reducer

Uses

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

Warnings

Warnings

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• More than 6 caplets in 24 hours, which is the maximum daily amount of this product.
• With other drugs containing acetaminophen.
• 3 or more alcoholic drinks everyday while using this product.

Allergy alert: Acetaminophen may cause severe skin reactions.
Symptoms may include:

• Skin reddening.
• Blisters.
• Rash

If 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.
• If you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have

lliver disease

Ask your doctor or pharmacist before use if you are

• Taking the blood thinning drug warfarin

Stop use and ask a doctor if

• Pain gets worse or lasts more than 10 days.
• 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

In case of overdose, get medical help or contact a Poison Control Center righ 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 of age and over:
  • ​Take 2 caplets every 6 hours while symptoms last.
  • Do not take more than 6 caplets in 24 hours unless directed by a doctor.
  • Do not use for more than 10 days unless directed by a doctor
• Children under 12 years: Do not use this extra strenght product. This will provide more than recommended dose (overdose) and could cause serious health problems.

Other information

• Store at controlled room temperature 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:

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Principal Display Panel

NDC: 85786-102-90

Extra Strenght

Pain Reliever

Acetaminophen 500 mg

Pain Reliever/Fever Reducer

100 Caplets

Aspirin Free

For Aduls

INGREDIENTS AND APPEARANCE

DR SIMI PAIN RELIEF 100 
acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85786-102
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

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

Product Characteristics
Color	white	Score	2 pieces
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	S500
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85786-102-90	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2025

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(85786-102) , analysis(85786-102) , pack(85786-102) , label(85786-102)