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NDC 00363-0158-46 walprofen congestion relief and pain 200; 10 mg/1; mg/1 Details
walprofen congestion relief and pain 200; 10 mg/1; mg/1
walprofen congestion relief and pain is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. The primary component is IBUPROFEN; PHENYLEPHRINE 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: 00363-0158-46Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ibuprofen
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 00363-0158-46Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 00363-0158 |
|---|---|
| Product ID | 0363-0158_95ff4033-7664-4e25-bb06-8360b1832b0c |
| 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 | walprofen congestion relief and pain |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ibuprofen, phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 200; 10 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Walgreen Company |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA203200 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 00363-0158-46 (00363015846)
| NDC Package Code | 0363-0158-46 |
|---|---|
| Billing NDC | 00363015846 |
| Package | 10 BLISTER PACK in 1 CARTON (0363-0158-46) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
| Marketing Start Date | 2017-07-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d9a566c2-9683-4a4e-892e-1e4ea48a1e54 Details
Active ingredients (in each tablet)
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 because this product contains too much medication for children under this 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
- •
- pain gets worse or lasts more than 7 days
- •
- 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
- •
- adults and children 12 years of age and over:
- •
- take 1 tablet every 4 hours while symptoms persist.
- •
- do not use more than 6 tablets in any 24-hour period unless directed by a doctor
- •
- children under 12 years of age: do not use because this product contains too much medication for children under this age
Other information
Inactive ingredients
acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide
Principal Display Panel
Compare to Advil® Sinus Congestion & Pain active ingredients
Wal-Profen®
SINUS CONGESTION & PAIN
IBUPROFEN 200 mg / PAIN RELIEVER / FEVER REDUCER (NSAID)
PHENYLEPHRINE HYDROCHLORIDE 10 mg / NASAL DECONGESTANT, TABLETS
NON-DROWSY
Relief of: Nasal Congestion, Headache, Sinus Pressure, Fever, Nasal Swelling, Body Aches
ACTUAL SIZE
10 COATED TABLETS
SEE NEW WARNINGS
ONE TABLET DOSE!
INGREDIENTS AND APPEARANCE
| WALPROFEN CONGESTION RELIEF AND PAIN
ibuprofen, phenylephrine hcl tablet, film coated |
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| Labeler - Walgreen Company (008965063) |