Label: ADVIL LIQUIGELS- ibuprofen capsule, liquid filled
- NDC Code(s): 67751-148-01, 67751-148-02, 67751-148-03
- Packager: Navajo Manufacturing Company Inc.
- This is a repackaged label.
- Source NDC Code(s): 0573-0169
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated March 15, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each capsule)
- Uses
-
Warnings
Allergy alert: Ibuprofen 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 surgeryAsk a doctor before use if
• stomach bleeding warning applies to you
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
• you are taking a diureticAsk a doctor or pharmacist before use if you are
• under a doctor’s care for any serious condition
• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• taking any other drugWhen using this product
• take with food or milk if stomach upset occurs
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directedStop use and ask a doctor if
• you expereince 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
• redness or swelling is present in the painful area
• any new symptoms appear -
Directions
• do not take more than directed
• the smallest effective dose should be used
• adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist
• if pain or fever does not respond to 1 capsule, 2 capsules may be used
• do not exceed 6 capsules in 24 hours, unless directed by a doctor
• children under 12 years: ask a doctor - Other information
- Inactive ingredients
- Questions or comments?
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
ADVIL LIQUIGELS
ibuprofen capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67751-148(NDC:0573-0169) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg Inactive Ingredients Ingredient Name Strength COCONUT OIL (UNII: Q9L0O73W7L) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) GELATIN (UNII: 2G86QN327L) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color green (Transparent green to blue green) Score no score Shape CAPSULE (oblong softgel) Size 20mm Flavor Imprint Code Advil Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67751-148-01 1 in 1 CARTON 09/20/2016 09/20/2016 1 4 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:67751-148-02 1 in 1 CARTON; Type 0: Not a Combination Product 06/13/2018 3 NDC:67751-148-03 2 in 1 CARTON; Type 0: Not a Combination Product 09/20/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020402 09/20/2016 Labeler - Navajo Manufacturing Company Inc. (091917799) Establishment Name Address ID/FEI Business Operations Navajo Manufacturing Company Inc. 136941411 relabel(67751-148) , repack(67751-148)
