Indications and uses
Temporarily relieves minor aches and pains due to: Headache. Muscular aches. Backache. Minor pain of arthritis. The common cold. Toothache. Premenstrual and menstrual cramps. Temporarily reduces fever.
Dr Simi Pain Relief
- 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
Active ingredientACETAMINOPHEN
Label structure10 sections
Dosage and administration
Do not take more than directed (see overdose warning). 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...
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
Active ingredient (in each caplet)
- Acetaminophen 325 mg
Purpose
Purpose
Pain reliever / Fever reducer
Uses
- Temporarily relieves minor aches and pains due to:
- Headache.
- Muscular aches.
- Backache.
- Minor pain of arthritis.
- The common cold.
- Toothache.
- Premenstrual and menstrual cramps.
- Temporarily reduces fever.
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.
Ask a doctor before use if the user has
liver disease.
Ask a doctor or pharmacist before use if the user is
taking the blood thinning drug warfarin.
Stop use and ask doctor if
- Pain gets worse or lasts more than 10 days in adults.
- Pain gets worse or lasts more than 5 days in children under 12 years.
- 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
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.
Directions
- Do not take more than directed (see overdose warning).
Directions
Adults and children 12 years and over |
|
| Children 6 years to under 12 years |
|
| Children under 6 years | Ask a doctor |
Other information
- Store between 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
LOT#
EXP:
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Principal display panel
DR SIMI
NDC 85786-103-90
Regular Strength
Pain Reliever
Acetaminophen 325 mg
Pain Reliever/ Fever Reducer
100 Caplets
Aspirin Free
For Adults
DailyMed RxNorm Mappings#
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0850070048552 | GTIN-13: 0850070048552 EAN-13: 0850070048552 GTIN-12: 850070048552 UPC-A: 850070048552 GTIN storage (14 digits): 00850070048552 | Principal Display Panel Acetaminophen 325.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85786-103-90 | Dr Simi Pain Relief | 100 in 1 BOTTLE | TABLET, COATED | 100 | 1 |
Products#
Every source-derived product name is available through these pages.
- Dr Simi Pain Relief
- Acetaminophen
- TITANIUM DIOXIDE
- WATER
- MAGNESIUM STEARATE
- HYPROMELLOSES
- POVIDONE K30
- TALC
- POLYETHYLENE GLYCOL 400
- STARCH, CORN
- MICROCRYSTALLINE CELLULOSE
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85786-103 | 85786-103-90 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| WATER | 059QF0KO0R | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| TALC | 7SEV7J4R1U | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| STEARIC ACID | 4ELV7Z65AP | 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 | ACETAMINOPHEN | Farmacias De Similares TX LLC | 3c477d33-a8c2-d39f-e063-6294a90ac5f0 | 2025-08-13 | Warnings | 85786-103-90 85786-103 85786010390 3c477d33-a8c3-d39f-e063-6294a90ac5f0 3c477d33-a8c2-d39f-e063-6294a90ac5f0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.