Drug Facts
Active ingredient (in each caplet)
- Acetaminophen 325 mg
The following Structured Product Label (SPL) was submitted to the FDA by Farmacias De Similares Tx Llc for the product Dr Simi Pain Relief (NDC 85786-103). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, do not use, ask a doctor before use if the user has, ask a doctor or pharmacist before use if the user is, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient (in each caplet)
Purpose
Pain reliever / Fever reducer
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.
liver disease.
taking the blood thinning drug warfarin.
These could be signs of a serious condition.
ask a health professional before use.
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.
Adults and children 12 years and over |
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| Children 6 years to under 12 years |
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| Children under 6 years | Ask a doctor |
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Hypromellose, Magnesium stearate, Microcrystalline Cellulose , Polyethylene glycol 400, Povidone, Pregelatinized Starch, Purified water, Stearic acid , Talc, Titanium Dioxide.
(855)-280-1079
Distributed by: FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA.
www.drsimi.com
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DR SIMI
NDC 85786-103-90
Regular Strength
Pain Reliever
Acetaminophen 325 mg
Pain Reliever/ Fever Reducer
100 Caplets
Aspirin Free
For Adults
* Please review the disclaimer below.