Rapidol Naproxen Display 25x2 (Deactivating)

Rapidol Naproxen by

Drug Labeling and Warnings

Rapidol Naproxen by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RAPIDOL NAPROXEN- naproxen sodium tablet, coated 
Pharmadel LLC

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Rapidol Naproxen Display 25x2 (Deactivating)

Drug Facts

Drug Facts

Active ingredients

Active ingredient (in each caplet)	Purpose
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID*).............	Pain reliever/; fever reducer

Uses

Temporarily relieves minor aches and pains due to:

• minor pain of arthritis
• backache
• the common cold
• temporarily reduces fever
• muscular aches
• menstrual cramps
• headache
• toothache

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

• 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 asthma
• 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

When using this product

• take with food or milk if stomach upset occurs
• the risk of a heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if you expirience 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
• 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
• you develop heartburn
• 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

• do not take more than directed
• the smallest effective dose should be used
• do not take longer than 10 days, unless directed by a doctor (see Warnings)
• drink a full glass of water with each dose

• 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:
  • ask a doctor

Other information

• each tablet contains: sodium 21 mg
• store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
• retain carton for complete product information

TAMPER EVIDENT: Do not use if box or individual packets are broken or torn.

Inactive ingredients

croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, corn starch (pregelatinzed), talc, titanium dioxide

Principal Display Panel

Rapidol® All Day Relief

NAPROXEN

PAIN RELIEVER/FEVER REDUCER (NSAID)
NAPROXEN SODIUM Tablets, 220 mg

• For Headaches
• Body Aches
• Menstrual Cramps
• Minor Arthritis Pain

25 packets of 2 Tablets each

RAPIDOL NAPROXEN 
naproxen sodium tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-320
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)	NAPROXEN SODIUM	220 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	blue	Score	score with uneven pieces
Shape	OVAL	Size	12mm
Flavor		Imprint Code	220
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-320-50	25 in 1 CARTON	01/18/2021	12/31/2023
1	NDC: 55758-320-01	2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 55758-320-01	2 in 1 POUCH; Type 0: Not a Combination Product	01/18/2021	12/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091353	01/18/2021	12/31/2023

Labeler - Pharmadel LLC (030129680)

Revised: 10/2023

Document Id: 088d7b64-26d1-def6-e063-6394a90a092e

34390-5

Set id: 9fa548e5-a2b5-7421-e053-2995a90ab871

Version: 7

Effective Time: 20231025