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NDC 46122-0609-58 Ibuprofen and Pseudoephedrine HCl 200; 30 mg/1; mg/1 Details
Ibuprofen and Pseudoephedrine HCl 200; 30 mg/1; mg/1
Ibuprofen and Pseudoephedrine HCl is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Amerisource Bergen. The primary component is IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). It is also used to relieve mild to moderate pain, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription ibuprofen is used to reduce fever and to relieve minor aches and pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Ibuprofen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.
Related Packages: 46122-0609-58Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ibuprofen
Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.
Related Packages: 46122-0609-58Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
NDC | 46122-0609 |
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Product ID | 46122-609_7569aff6-da0d-46b9-b7c4-bf2766827013 |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Ibuprofen and Pseudoephedrine HCl |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Ibuprofen and Pseudoephedrine HCl |
Product Type | HUMAN OTC DRUG |
Dosage Form | CAPSULE, LIQUID FILLED |
Route | ORAL |
Active Ingredient Strength | 200; 30 |
Active Ingredient Units | mg/1; mg/1 |
Substance Name | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE |
Labeler Name | Amerisource Bergen |
Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-Adrenergic Agonist [EPC] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA209235 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 46122-0609-58 (46122060958)
NDC Package Code | 46122-609-58 |
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Billing NDC | 46122060958 |
Package | 4 BLISTER PACK in 1 CARTON (46122-609-58) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
Marketing Start Date | 2017-12-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 8d397f4f-ac5e-426d-a26b-ee064b6e5028 Details
Drug Facts
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.
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
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
If pregnant or breast-feeding,
Keep out of reach of children.
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)
GOOD
NEIGHBOR
PHARMACY®
*Compare to the Advil® Cold & Sinus
active ingredients
NDC 46122-609-58
Non-Drowsy
COLD & SINUS RELIEF
Ibuprofen and Pseudoephedrine HCl Capsules
200 mg/30 mg
Pain Reliever/Fever Reducer (NSAID)/Nasal Decongestant
- Relieves Sinus Pressure, Nasal Congestion and Fever
40 Liquid-Filled Capsules (4 X 10 capsules per blister card)
INGREDIENTS AND APPEARANCE
IBUPROFEN AND PSEUDOEPHEDRINE HCL
ibuprofen and pseudoephedrine hcl capsule, liquid filled |
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Labeler - Amerisource Bergen (007914906) |
Registrant - Aurohealth LLC (078728447) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Aurobindo Pharma Limited | 650381903 | ANALYSIS(46122-609) , MANUFACTURE(46122-609) |