RAPIDOL NAPROXEN- naproxen sodium tablet, coated 
Pharmadel LLC

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Rapidol Naproxen 220mg (HL)

Drug Facts

Drug Facts

Active ingredient & Purposes

Active ingredient & Purposes

Active ingredient (in each caplet) Purposes

Naproxen sodium 220mg

(naproxen 200mg) (NSAID*)

Pain reliver/ fever reducer
*nonsteroidal anti-inflammatory drug

Uses

Warnings

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

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

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

Heart attack and stroke warning: NSAIDs, exept 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.

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,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

Ask a doctor or pharmacist before use if you are

  • under a doctor's care for any serious condition
  • taking any other drug
  • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin

When using this product

  • take with food or milk if stomach upset occurs

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 sysmptoms 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
  • 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.

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

Directions

adults and children 12 years and older
  • 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- to 12-hour period
  • do not exceed 3 caplets in a 24-hour period
children under 12 years of age
  • ask a doctor

Other information

Inactive ingredients

corn starch, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polythylene glycol, povidone K30, sodium starch glycolate, stearic acid, titanium dioxide, water

Distributed by:

This product is not manufactured or distributed by Bayer Health LLC., distributor of Aleve. Aleve is a registered mark of bayer Health LLC.

PHARMADEL LLC

New Castle, DE 19720

www.pharmadel.com

(f)/ PharmadelUSA

1-866-359-3478

Prrinicpal Display Panel

55758-048-24

Rapidol Naproxen Sodium 220mg

24 Caplets

24 Bottle Naproxen

RAPIDOL NAPROXEN 
naproxen sodium tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-048
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
STARCH, CORN (UNII: O8232NY3SJ)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorblue (Light Blue) Scorescore with uneven pieces
ShapeOVAL ((Caplet Shaped)) Size12mm
FlavorImprint Code 220
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-048-241 in 1 CARTON10/09/2019
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:55758-048-5025 in 1 CARTON10/24/2023
2NDC:55758-048-022 in 1 PACKET; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09135310/09/2019
Labeler - Pharmadel LLC (030129680)

Revised: 4/2023
Document Id: f91123b7-f4d5-6b11-e053-6294a90a9536
Set id: c94c4b6e-a48b-cee5-e053-2995a90a49ac
Version: 7
Effective Time: 20230411
 
Pharmadel LLC