Label: DR SIMI PAIN RELIEF- acetaminophen tablet, coated
- NDC Code(s): 85786-103-90
- Packager: Farmacias De Similares TX LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated August 13, 2025
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- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
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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.
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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
- Inactive ingredients
- Questions or comments?
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INGREDIENTS AND APPEARANCE
DR SIMI PAIN RELIEF
acetaminophen tablet, coatedProduct 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)
