signature care naproxen sodium

Manufacturer
Safeway
Effective date
2025-12-16
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:25:44

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each caplet)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

Uses

• temporarily relieves minor aches and pains due to: • minor pain of arthritis • muscular aches • backache • menstrual cramps • headache • toothache • the common cold • temporarily reduces fever

Warnings

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 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 And Dosage

Directions

• do not take more than directed • the smallest effective dose should be used • 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 Label Information

Other information

• each caplet contains: sodium 22 mg • store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).

Inactive ingredients

FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Aleve ® active ingredient Signature care ® Quality Guaranteed Naproxen Sodium TABLETS, 220 mg Pain Reliever/Fever Reducer (NSAID) Strength to last 12 hours Actual Size 90 CAPLETS** **Capsule-Shaped Tablets

Label Images

signature-care-naproxen-sodium-carton-image
signature-care-naproxen-sodium-carton-image

Products

NDC Codes

Ingredients

Complete SPL Sections

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

• temporarily relieves minor aches and pains due to: • minor pain of arthritis • muscular aches • backache • menstrual cramps • headache • toothache • the common cold • temporarily reduces fever

Warnings

WARNINGS SECTION

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 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

DOSAGE & ADMINISTRATION SECTION

• do not take more than directed • the smallest effective dose should be used • 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 caplet contains: sodium 22 mg • store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Aleve ® active ingredient Signature care ® Quality Guaranteed Naproxen Sodium TABLETS, 220 mg Pain Reliever/Fever Reducer (NSAID) Strength to last 12 hours Actual Size 90 CAPLETS** **Capsule-Shaped Tablets

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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XML bytes
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Legacy File Index

FolderFileDate
otc347809fc-ce5e-49ff-b4e5-a36aa9eb6a72.xml2025-12-17
otc6bf6778a-0516-4cf4-8542-3249feea88e5.xml2025-03-08
otcsignature-care-naproxen-sodium-carton-image.jpg2025-03-08
otc2b1d2ad6-0214-4af4-aa70-47c3b14e6faf.xml2022-04-28
otcb11dea07-85f8-4631-bdd4-2058d284874d.xml2021-12-02
otcimage-01.jpg2021-12-02
otc9f1bc7f6-a4a0-4350-ba71-e66fd13ef160.xml2019-12-17
otc368 LJ naproxen-sodium-image.jpg2018-05-01
otc85f78e63-98aa-4cf3-887d-0ac535184f97.xml2018-05-01