Indications and 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.
Dr Simi Pain Relief 100
- Manufacturer
- Farmacias De Similares TX LLC | Elysium Pharmacuticals Ltd
- Effective date
- 2025-08-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:33:52
Label at a glance#
ProductDr Simi Pain Relief 100
Active ingredientACETAMINOPHEN
Label structure10 sections
Dosage and administration
Do not take more than directed (see overdose warning). 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 ca...
Contacts and useful links#
Label contents#
Full prescribing information#
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 |
|
| 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:
PEEL BACK for more DRUG FACTS
Principal Display Panel
NDC 85786-102-90
Extra Strenght
Pain Reliever
Acetaminophen 500 mg
Pain Reliever/Fever Reducer
100 Caplets
Aspirin Free
For Aduls
DailyMed RxNorm Mappings#
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0850070048828 | GTIN-13: 0850070048828 EAN-13: 0850070048828 GTIN-12: 850070048828 UPC-A: 850070048828 GTIN storage (14 digits): 00850070048828 | Principal Display Panel Acetaminophen.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85786-102-90 | Dr Simi Pain Relief 100 | 100 in 1 BOTTLE | TABLET, COATED | 100 | 1 |
Products#
Every source-derived product name is available through these pages.
- Dr Simi Pain Relief 100
- Acetaminophen
- TALC
- STARCH, CORN
- TITANIUM DIOXIDE
- WATER
- STEARIC ACID
- POVIDONE K30
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- HYPROMELLOSES
- POLYETHYLENE GLYCOL 400
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85786-102 | 85786-102-90 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TALC | 7SEV7J4R1U | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| WATER | 059QF0KO0R | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Dr Simi Pain Relief 100 | ACETAMINOPHEN | Farmacias De Similares TX LLC | 3c42e48d-cdb2-eb74-e063-6394a90a2940 | 2025-08-13 | Warnings | 85786-102-90 85786-102 85786010290 3c42e48d-cdb3-eb74-e063-6394a90a2940 3c42e48d-cdb2-eb74-e063-6394a90a2940 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.