All Day Pain Relief Naproxen

All Day Pain Relief Naproxen
SPL v1
SPL
SPL Set ID 3c6d4bb5-eb6f-944b-e063-6294a90ae8de
Route
ORAL
Published
Effective Date 2025-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naproxen (220 mg)
Inactive Ingredients
Hypromellose, Unspecified Titanium Dioxide Silicon Dioxide Magnesium Stearate Povidone K30 Croscarmellose Sodium Microcrystalline Cellulose Fd&c Blue No. 2 Aluminum Lake Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: 220 Shape: oval Color: blue Size: 12 mm Score: 1
Marketing Status
ANDA Active Since 2025-08-17

Description

Active ingredient (in each caplet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *Nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer


Medication Information

Purpose
  • Pain reliever/fever reducer
Dosage and Administration
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.

Description

Active ingredient (in each caplet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *Nonsteroidal anti-inflammatory drug

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.
Section 34088-5

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

Section 42229-5

Distributed by: FARMACIAS DE SIMILARES TX LLC

800 Brazos St Ste 260, Austin, TX, 78701, USA.

[email protected]

www.drsimi.com

LOT #

EXP:

PEEL BACK for more DRUG FACTS

Section 51945-4

DR SIMI

NDC 85786-104-24

Strength to Last 12 hours

Naproxen Sodium 220 mg

Pain Reliever/Fever Reducer (NSAID)

24 Caplets

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

Do Not Use
  • If you have ever had an allergic reaction to any other pain reliever/fever reducer.
  • Right before or after heart surgery.
Drug Facts

Active ingredient (in each caplet)

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

*Nonsteroidal anti-inflammatory drug

Other 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

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

Questions Or Comments?

(855)-280-1079

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.
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.
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

Ask A Doctor Or Pharmacist Before Use If You Are
  • Under a doctor's care for any serious condition.
  • Taking any other drug.

Structured Label Content

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 (34068-7)
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.

Section 34088-5 (34088-5)

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

Section 42229-5 (42229-5)

Distributed by: FARMACIAS DE SIMILARES TX LLC

800 Brazos St Ste 260, Austin, TX, 78701, USA.

[email protected]

www.drsimi.com

LOT #

EXP:

PEEL BACK for more DRUG FACTS

Section 51945-4 (51945-4)

DR SIMI

NDC 85786-104-24

Strength to Last 12 hours

Naproxen Sodium 220 mg

Pain Reliever/Fever Reducer (NSAID)

24 Caplets

Purpose
  • Pain reliever/fever reducer
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.
Directions
  • Do not take more than directed.
  • The smallest effective dose should be used
  • Drink a full glass of water with each dose.

Do Not Use (Do not use)
  • If you have ever had an allergic reaction to any other pain reliever/fever reducer.
  • Right before or after heart surgery.
Drug Facts

Active ingredient (in each caplet)

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

*Nonsteroidal anti-inflammatory drug

Other Information (Other 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 ingredients)

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

Questions Or Comments? (Questions or comments?)

(855)-280-1079

When Using This Product (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.
Ask A Doctor Before Use If (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.
Stop Use and Ask Doctor If (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 (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)

Keep out of reach of children

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • Under a doctor's care for any serious condition.
  • Taking any other drug.

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)