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NDC 51660-0423-21 Ibuprofen and Pseudoephedrine hydrochloride 200; 30 mg/1; mg/1 Details
Ibuprofen and Pseudoephedrine hydrochloride 200; 30 mg/1; mg/1
Ibuprofen and Pseudoephedrine hydrochloride is a ORAL TABLET, SUGAR COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Ohm Laboratories Inc.. 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: 51660-0423-21Last 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: 51660-0423-21Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
| NDC | 51660-0423 |
|---|---|
| Product ID | 51660-423_cd566d12-38cf-4ae5-961e-427c64660c5d |
| 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 hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ibuprofen and pseudoephedrine hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, SUGAR COATED |
| Route | ORAL |
| Active Ingredient Strength | 200; 30 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Labeler Name | Ohm Laboratories Inc. |
| 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 | ANDA074567 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 51660-0423-21 (51660042321)
| NDC Package Code | 51660-423-21 |
|---|---|
| Billing NDC | 51660042321 |
| Package | 20 TABLET, SUGAR COATED in 1 BLISTER PACK (51660-423-21) |
| Marketing Start Date | 2001-10-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 65ec0f85-7ca3-4adc-b152-a0ae2fd0692f Details
SPL UNCLASSIFIED SECTION
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:
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- are age 60 or older
- •
- have had stomach ulcers or bleeding problems
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- 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
- •
- under a doctor's care for any serious condition
- •
- taking any other product that contains pseudoephedrine or any other nasal decongestant
- •
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- •
- taking any other drug
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
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- symptoms continue or get worse
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- redness or swelling is present in the painful area
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- you get nervous, dizzy, or sleepless
- •
- any new symptoms appear
Directions
- •
- do not take more than directed
- •
- the smallest effective dose should be used
- •
- adults and children 12 years of age and over:
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- take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used.
- •
- do not use more than 6 caplets in any 24-hour period unless directed by a doctor
- •
- children under 12 years of age: do not use
Other information
Inactive ingredients
acacia, calcium carbonate, carnauba wax, confectioner's sugar, corn starch, croscarmellose sodium, crospovidone, FD&C Blue no. 2 Aluminum Lake, FD&C Red no. 40 Aluminum Lake, FD&C Yellow no. 6 Aluminum Lake, gelatin, guar gum, hydrogenated vegetable oil, hydroxypropyl cellulose, iron oxide black, kaolin, polyethylene glycol, powdered cellulose, povidone, pregelatinized starch, propylene glycol, shellac, silicon dioxide, sodium benzoate, sucrose, talc, titanium dioxide, white wax
PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton
†Compare To
the active ingredients of
Advil® Cold & Sinus
NDC 51660-423-21
See New Warnings Information
ohm®
Non-Drowsy
Cold & Sinus
Ibuprofen and Pseudoephedrine
HCl Tablets, USP
Ibuprofen, USP 200 mg – Pain Reliever/Fever Reducer (NSAID)*
Pseudoephedrine HCl, USP 30 mg – Nasal Decongestant
*nonsteroidal anti-inflammatory drug
- •
-
Relieves Sinus Pressure,
Nasal Congestion and Fever
20 Coated Caplets**
(**oval-shaped tablets)
INGREDIENTS AND APPEARANCE
| IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
ibuprofen and pseudoephedrine hydrochloride tablet, sugar coated |
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| Labeler - Ohm Laboratories Inc. (184769029) |
| Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Ohm Laboratories Inc. | 184769029 | MANUFACTURE(51660-423) | |