Dr Simi All Day Pain Relief

Manufacturer: Farmacias De Similares TX LLC | Granules India Limited
Effective date: 2025-08-15
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 All Day Pain Relief

Active ingredientNAPROXEN SODIUM

Label structure10 sections

Indications and uses

Temporarily relieves minor aches and pains due to: Minor pain of arthritis. Backache. Headache. Muscular aches. Menstrual cramps. Toothache. The common cold. Temporarily reduces fever.

Dosage and administration

Do not take more than directed. The smallest effective dose should be used Drink a full glass of water with each dose. Adults and children 12 years and over: Take 1 caplet every 8 to 12 hours while symptoms last. For the first dose you may take 2 caplets within the first hour. Do not exceed 2 caplets in any 8-12 hour period. Do not exceed 3 caplets in a 24-hour period. Children under 12 years: Ask a doctor.

Contacts and useful links#

PhoneLabel contact(855)-280-1079

Websitewww.drsimi.com

www.drsimi.com

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*

*Nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

SPL UNCLASSIFIED SECTION

Temporarily relieves minor aches and pains due to:
Minor pain of arthritis.
Backache.
Headache.
Muscular aches.
Menstrual cramps.
Toothache.
The common cold.
Temporarily reduces fever.

Warnings

WARNINGS SECTION

Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

Hives
Facial swelling
Asthma (wheezing)
Shock
Skin reddening
Rash
Blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

Are age 60 or older.
Have had stomach ulcers or bleeding problems.
Take a blood thinning (anticoagulant) or steroid drug.
Take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others].
Have 3 or more alcoholic drinks every day while using this product.
Take more or for a longer time than directed.

Do not use

OTC - DO NOT USE SECTION

If you have ever had an allergic reaction to any other pain reliever/fever reducer.
Right before or after heart surgery.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

The stomach bleeding warning applies to you.
You have a history of stomach problems, such as heartburn
You have high blood pressure, heart disease, liver cirrhosis, or kidney disease.
You are taking a diuretic
You have problems or serious side effects from taking pain relievers or fever reducers.
You have asthma.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

Under a doctor's care for any serious condition.
Taking any other drug.

When using this product

OTC - WHEN USING SECTION

Take with food or milk if stomach upset occurs.
The risk of heart attack or stroke may increase if you use more than directed or for longer than directed.

Stop use and ask doctor if

OTC - STOP USE SECTION

You experience any of the following signs of stomach bleeding:
- Feel faint.
- Have bloody or black stools.
- Vomit blood.
- Have stomach pain that does not get better.
You have symptoms of heart problems or stroke:
Chest Pain
Trouble breathing
Weakness in one side of the body
Slurred speech
Leg swelling
Pain gets worse or lasts more than 10 days.
Fever gets worse or lasts more than 3 days.
You have difficulty swallowing.
It feels like the pill is stuck in your throat.
Redness or swelling is present in the painful area.
Any new symptoms appear.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. It is especially important not to use Naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

INDICATIONS & USAGE SECTION

Do not take more than directed.
The smallest effective dose should be used
Drink a full glass of water with each dose.

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and over:	Take 1 caplet every 8 to 12 hours while symptoms last. For the first dose you may take 2 caplets within the first hour. Do not exceed 2 caplets in any 8-12 hour period. Do not exceed 3 caplets in a 24-hour period.
Children under 12 years:	Ask a doctor.

Other information

OTHER SAFETY INFORMATION

Each tablet contains: sodium 20 mg.
Store at room temperature 15-30°C (59-86°F).
Read all product information before use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Lake, hypromellose, magnesium stearate, mirocrystalline cellulose, polyethylene glycol, povidone, titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

(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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DR SIMI

NDC 85786-104-24

Strength to Last 12 hours

Naproxen Sodium 220 mg

Pain Reliever/Fever Reducer (NSAID)

24 Caplets

PDP

DF1

DF2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
849574	naproxen sodium 220 MG Oral Tablet	PSN	1
849574	naproxen sodium 220 MG Oral Tablet	SCD	1
849574	naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
NAPROXEN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20191108

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0850072692876	GTIN-13: 0850072692876 EAN-13: 0850072692876 GTIN-12: 850072692876 UPC-A: 850072692876 GTIN storage (14 digits): 00850072692876	PDP Naproxen Sodium 220 mmg .jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fef6ad89-235f-4274-ba49-a8e53642473e	Product name	2	20250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ff	Product name	3	20230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8	Product name	1	20200623
e76dbbc1-775d-722c-08ff-ed45e8a80def	Product name	3	20181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7c	Product name	1	20140508
ce67e27d-1d21-5465-4409-b0662dd99d4d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85786-104-24	Dr Simi All Day Pain Relief	24 in 1 BOTTLE	TABLET, FILM COATED	24		1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Dr Simi All Day Pain Relief
Naproxen sodium
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
NAPROXEN
SILICON DIOXIDE
MAGNESIUM STEARATE
POVIDONE K30
CROSCARMELLOSE SODIUM
MICROCRYSTALLINE CELLULOSE
FD&C BLUE NO. 2 ALUMINUM LAKE
POLYETHYLENE GLYCOL, UNSPECIFIED

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
85786-104	85786-104-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
NAPROXEN SODIUM	9TN87S3A3C	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POVIDONE K30	U725QWY32X	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
FD&C BLUE NO. 2 ALUMINUM LAKE	4AQJ3LG584	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091353-001	NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET / ORAL			2011-09-20

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091353-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2011-09-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091353-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2011-09-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`f41ea6bd6efb…`

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr Simi All Day Pain Relief	NAPROXEN SODIUM	Farmacias De Similares TX LLC	3c6d4bb5-eb6f-944b-e063-6294a90ae8de	2025-08-15	Warnings	Exact identifier ndc (package): 85786-104-24 ndc (product): 85786-104 ndc11 (package): 85786010424 spl id: 3c6d4bb5-eb70-944b-e063-6294a90ae8de spl set id: 3c6d4bb5-eb6f-944b-e063-6294a90ae8de

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.