Label: ALEVE LIQUID GELS- naproxen sodium capsule, liquid filled
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NDC Code(s):
0280-0105-01,
0280-0105-02,
0280-0105-03,
0280-0105-04, view more0280-0105-05, 0280-0105-06
- Packager: Bayer Healthcare LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 6, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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.
- DO NOT USE
-
ASK DOCTOR
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, 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 DOCTOR/PHARMACIST
- WHEN USING
-
STOP USE
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
- weakness in one part or side of body
- leg swelling
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
- you have difficulty swallowing
- it feels like the capsule is stuck in your throat
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- do not take more than directed
- the smallest effective dose should be used
- drink a full glass of water with each dose
- if taken with food, this product may take longer to work
Adults and children 12
years and older- take 1 capsule every 8 to 12 hours
while symptoms last - for the first dose you may take
2 capsules within the first hour - do not exceed 2 capsules in any
8- to 12-hour period - do not exceed 3 capsules in a
24-hour period
Children under 12 years - ask a doctor
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL - 160 Capsules Label
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL - 20 Capsules Label
- PRINCIPAL DISPLAY PANEL - 20 Capsules Carton
- PRINCIPAL DISPLAY PANEL - 50 Capsules Label
- PRINCIPAL DISPLAY PANEL - 50 Capsules Carton
- PRINCIPAL DISPLAY PANEL - 80 Capsules Label
- PRINCIPAL DISPLAY PANEL - 80 Capsules Carton
- PRINCIPAL DISPLAY PANEL - 80 Capsules Label
- PRINCIPAL DISPLAY PANEL - 80 Capsules Carton
- PRINCIPAL DISPLAY PANEL - 120 Capsules Label
- PRINCIPAL DISPLAY PANEL - 120 Capsules Carton
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INGREDIENTS AND APPEARANCE
ALEVE LIQUID GELS
naproxen sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-0105 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 AMMONIA (UNII: 5138Q19F1X) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) MANNITOL (UNII: 3OWL53L36A) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue (Blue with white text) Score no score Shape CAPSULE Size 25mm Flavor Imprint Code P797 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-0105-02 160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2023 2 NDC:0280-0105-03 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/07/2024 3 NDC:0280-0105-04 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/14/2024 4 NDC:0280-0105-05 80 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/21/2024 5 NDC:0280-0105-06 80 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/17/2024 6 NDC:0280-0105-01 120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/28/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214463 12/01/2023 Labeler - Bayer Healthcare LLC (112117283) Registrant - Bayer Healthcare LLC (072827066) Establishment Name Address ID/FEI Business Operations Patheon Softgels Inc. 002193829 manufacture(0280-0105)
