Rapidol Naproxen 220mg (hhh)

Rapidol Naproxen 220mg (hhh)
SPL v10
SPL
SPL Set ID c94c4b6e-a48b-cee5-e053-2995a90a49ac
Route
ORAL
Published
Effective Date 2024-08-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naproxen (220 mg)
Inactive Ingredients
Hypromellose, Unspecified Fd&c Blue No. 2--aluminum Lake Starch, Corn Microcrystalline Cellulose Povidone K30 Sodium Starch Glycolate Type A Titanium Dioxide Polyethylene Glycol, Unspecified Stearic Acid Water

Identifiers & Packaging

Pill Appearance
Imprint: 220 Shape: oval Color: blue Size: 12 mm
Marketing Status
ANDA Active Since 2019-10-09

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • temporarily relieves minor aches and pains due to
  • minor pain from arthritis
  • menstrual cramps
  • muscular aches
  • headache
  • backache
  • toothache
  • the common cold
  • temporarily reduces fever
Section 55105-1
Active ingredient (in each caplet) Purposes

Naproxen sodium 220mg

(naproxen 200mg) (NSAID*)

Pain reliver/ fever reducer
*nonsteroidal anti-inflammatory drug

Warnings

Allergy alert: Naproxen sodium may cause severe skin reactions. 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

Heart attack and stroke warning:NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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

adults & children 12 years of age and older

  • take 1 tablet every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 tablets within the first hour
  • do not exceed 2 tablets in any 8 to 12 hour period
  • do not exceed 3 Tablets in a 24-hour period
children under 12 years of age
  • consult a doctor

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

Drug Facts

Other Information
  • each caplet contains: sodium 20 mg
  • store between 68-77°F (20-25°C). Avoid high humidity and excessive heat above 104°F (40°C)
Inactive Ingredients

corn starch, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone k30, sodium starch glycolate, stearic acid, titanium dioxide, water

When Using This Product
  • take with food or milk if stomach upset occurs
Prrinicpal Display Panel

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, kidney disease, asthma, or had a stroke
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
Stop Use and Ask A Doctor If
  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • slurred speech
  • leg swelling
  • weakness in one part or side of body

  • 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 at 20 weeks or later 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.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Distributed By/ Distribuido Por:

PHARMADEL LLC

New Castle, DE 19720

Questions? +1-866-359-3478

Made in India/ Hecho en India

†This product is not manufactured or distributed by Bayer Health Care LLC., distributor of Aleve® caplets. Aleve® is a registered mark of Bayer Health Care LLC.

Ask A Doctor Or Pharmacist Before Use If You Are
  • under a doctor’s care for any serious condition
  • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
  • taking any other drugs

Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to
  • minor pain from arthritis
  • menstrual cramps
  • muscular aches
  • headache
  • backache
  • toothache
  • the common cold
  • temporarily reduces fever
Section 55105-1 (55105-1)
Active ingredient (in each caplet) Purposes

Naproxen sodium 220mg

(naproxen 200mg) (NSAID*)

Pain reliver/ fever reducer
*nonsteroidal anti-inflammatory drug

Warnings

Allergy alert: Naproxen sodium may cause severe skin reactions. 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

Heart attack and stroke warning:NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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

adults & children 12 years of age and older

  • take 1 tablet every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 tablets within the first hour
  • do not exceed 2 tablets in any 8 to 12 hour period
  • do not exceed 3 Tablets in a 24-hour period
children under 12 years of age
  • consult a doctor

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

Drug Facts

Other Information (Other information)
  • each caplet contains: sodium 20 mg
  • store between 68-77°F (20-25°C). Avoid high humidity and excessive heat above 104°F (40°C)
Inactive Ingredients (Inactive ingredients)

corn starch, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone k30, sodium starch glycolate, stearic acid, titanium dioxide, water

When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs
Prrinicpal Display Panel

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, kidney disease, asthma, or had a stroke
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • slurred speech
  • leg swelling
  • weakness in one part or side of body

  • 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 at 20 weeks or later 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 right away (1-800-222-1222).

Distributed By/ Distribuido Por: (Distributed by/ Distribuido por:)

PHARMADEL LLC

New Castle, DE 19720

Questions? +1-866-359-3478

Made in India/ Hecho en India

†This product is not manufactured or distributed by Bayer Health Care LLC., distributor of Aleve® caplets. Aleve® is a registered mark of Bayer Health Care LLC.

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 aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
  • taking any other drugs

Advanced Ingredient Data


Raw Label Data

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