Dr Simi All Day Pain Relief

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Dr Simi All Day Pain Relief
Generic name
NAPROXEN SODIUM
Manufacturer
Farmacias De Similares TX LLC
Product type
HUMAN OTC DRUG
SPL set ID
3c6d4bb5-eb6f-944b-e063-6294a90ae8de
SPL ID
3c6d4bb5-eb70-944b-e063-6294a90ae8de
Version
1
Effective date
2025-08-15
Source export date
2026-09-28
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:15:49
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings 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 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 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 Under a doctor's care for any serious condition. Taking any other drug. When using this product 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 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 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 Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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