NDC | 58602-803-08, 58602-803-67, 58602-803-83 |
Set ID | 6adf9292-b4af-4cb4-99f3-dda03734570a |
Category | Human OTC Drug Label |
Packager | Aurohealth LLC |
Generic Name | |
Product Class | alpha-Adrenergic Agonist |
Product Number | |
Application Number | ANDA209235 |
- Drug Facts
- Purposes
- 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
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.
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Do not use
- in children under 12 years of age
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
-
Ask 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, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke
- you are taking a diuretic
- Ask a doctor or pharmacist before use if you are
- When using this product
-
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
- weakness in one part or side of body
- slurred speech
- leg swelling
- fever gets worse or lasts more than 3 days
- nasal congestion lasts for more than 7 days
- symptoms continue or get worse
- redness or swelling is present in the painful area
- you get nervous, dizzy, or sleepless
- any new symptoms appear
- you experience any of the following signs of stomach bleeding:
- If pregnant or breast-feeding,
- Keep out of reach of children.
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Directions
● do not take more than directed
● the smallest effective dose should be used
● adults and children 12 years of age and over:
● take 1 capsule every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 capsule, 2 capsules may be used.
● do not use more than 6 capsules in any 24-hour period unless directed by a doctor
● children under 12 years of age: do not use
Other information
- each capsule contains: potassium 20 mg
- store at 20° to 25°C (68° to 77°F). Avoid excessive heat above 40°C (104°F).
- read all warnings and directions before use. Keep carton.
-
Inactive ingredients
Black iron oxide, D&C yellow no. 10, gelatin, hypromellose, neelicert FD&C red no. 40, polyethylene glycol, potassium hydroxide, propylene glycol, sorbitol sorbitan solution.
Questions or comments? call 1-855-274-4122
Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648
Made in India
Code:TS/DRUGS/22/2009 -
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/30 mg (20 Liquid-Filled Capsules)
AUROHEALTH
NDC 58602-803-67
*Compare to the active
ingredients of Advil® Cold &SinusNon-Drowsy
COLD & SINUS RELIEFIbuprofen and Pseudoephedrine HCl Capsules
200 mg/30 mg
Ibuprofen 200 mg - Pain Reliever/Fever Reducer (NSAID)
Pseudoephedrine HCl 30 mg - Nasal Decongestant- Relieves Sinus Pressure
- Nasal Congestion and Fever
20 Liquid-Filled Capsules
(2 X 10 capsules per blister card)
-
INGREDIENTS AND APPEARANCE
IBUPROFEN AND PSEUDOEPHEDRINE HCL
ibuprofen and pseudoephedrine hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-803 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE (UNII: XM0M87F357) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) FD&C RED NO. 40 (UNII: WZB9127XOA) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) Product Characteristics Color ORANGE (Light Orange to Light Yellow with a Slight Orange hue) Score no score Shape OVAL Size 15mm Flavor Imprint Code IBP200 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-803-67 2 in 1 CARTON 12/01/2017 1 NDC:58602-803-83 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:58602-803-08 4 in 1 CARTON 12/01/2017 2 NDC:58602-803-83 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:58602-803-13 4 in 1 CARTON 12/01/2017 3 NDC:58602-803-79 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:58602-803-03 1 in 1 CARTON 01/17/2020 4 NDC:58602-803-83 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209235 12/01/2017 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650381903 ANALYSIS(58602-803) , MANUFACTURE(58602-803)