Drug Facts
| Active ingredient (in each caplet) | Purpose |
| Acetaminophen 500 mg | Pain reliever / Fever reducer |
Dr Simi Pain Relief 100 Tablet, Coated
FDA Label NDC 85786-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Farmacias De Similares Tx Llc for the product Dr Simi Pain Relief 100 (NDC 85786-102). 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 you have, ask your doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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.
- Skin reddening.
- Blisters.
- Rash
Allergy alert: Acetaminophen may cause severe skin reactions.
Symptoms may include:
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).
- 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
| Adults and children 12 years of age and over | |
| 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
Other
Distributed by: FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA.
[email protected]
www.drsimi.com
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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
* Please review the disclaimer below.
