Rapidol Naproxen

Manufacturer: Pharmadel LLC
Effective date: 2023-10-25
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: legacy-cache
Hydrated at: 2026-08-01 21:23:13

Label at a glance#

ProductRapidol Naproxen

Active ingredientNAPROXEN SODIUM

Label structure8 sections

Indications and 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

Dosage and administration

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...

Storage and handling

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.

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

under a doctor's care for any serious condition
taking any other drug

When using this product

OTC - WHEN USING SECTION

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:

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

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

Principal Display Panel

PACKAGE LABEL.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

Naproxen Display

Tablet Photo

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Rapidol Naproxen
Naproxen sodium
FD&C BLUE NO. 2
STARCH, CORN
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
POVIDONE, UNSPECIFIED
TALC
TITANIUM DIOXIDE
NAPROXEN
POLYETHYLENE GLYCOL, UNSPECIFIED
CROSCARMELLOSE SODIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55758-320	55758-320-01, 55758-320-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FD&C BLUE NO. 2	L06K8R7DQK	IACT
STARCH, CORN	O8232NY3SJ	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYVINYL ALCOHOL	532B59J990	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
NAPROXEN SODIUM	9TN87S3A3C	ACTIB
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091353-001	NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET / ORAL			2011-09-20

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091353-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2011-09-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091353-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2011-09-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091353-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-09-20	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
088d7b64-26d1-def6-e063-6394a90a092e			9fa548e5-a2b5-7421-e053-2995a90ab871	2023-10-25	Warnings	Exact identifier spl id: 088d7b64-26d1-def6-e063-6394a90a092e spl set id: 9fa548e5-a2b5-7421-e053-2995a90ab871

Reported adverse events (FAERS/openFDA)#

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