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NDC 36800-0417-01 Topcare Sinus and Cold D 220; 120 mg/1; mg/1 Details
Topcare Sinus and Cold D 220; 120 mg/1; mg/1
Topcare Sinus and Cold D is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Prescription naproxen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), juvenile arthritis (a form of joint disease in children), and ankylosing spondylitis (arthritis that mainly affects the spine). Prescription naproxen tablets, extended-release tablets, and suspension are also used to relieve shoulder pain caused by bursitis (inflammation of a fluid-filled sac in the shoulder joint), tendinitis (inflammation of the tissue that connects muscle to bone), gouty arthritis (attacks of joint pain caused by a build-up of certain substances in the joints), and pain from other causes, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription naproxen is used to reduce fever and to relieve mild pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Naproxen 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: 36800-0417-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Naproxen
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: 36800-0417-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
| NDC | 36800-0417 |
|---|---|
| Product ID | 36800-417_c0842c7e-dda1-47d3-9af9-da14f8f78e0a |
| 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 | Topcare Sinus and Cold D |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Naproxen sodium, Pseudoephedrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 220; 120 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Labeler Name | Topco Associates LLC |
| 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 | ANDA076518 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 36800-0417-01 (36800041701)
| NDC Package Code | 36800-417-01 |
|---|---|
| Billing NDC | 36800041701 |
| Package | 20 BLISTER PACK in 1 CARTON (36800-417-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
| Marketing Start Date | 2013-08-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 55c177ce-1729-4a9b-a5ae-2b6c96fbc27a Details
Active ingredients (in each caplet)
Uses
Warnings
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- •
- hives
- •
- facial swelling
- •
- asthma (wheezing)
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- shock
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- skin reddening
- •
- rash
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- 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
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- have had stomach ulcers or bleeding problems
- •
- take a blood thinning (anticoagulant) or steroid drug
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- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
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- have 3 or more alcoholic drinks every day while using this product
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- 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
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- if you have ever had an allergic reaction to any other pain reliever/fever reducer
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- 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.
- •
- in children under 12 years of age
Ask a doctor before use if
- •
- the stomach bleeding warning applies to you
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- you have a history of stomach problems, such as heartburn
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- 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
- •
- you have problems or serious side effects from taking pain relievers or fever reducers
Ask 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 naproxen 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
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- have stomach pain that does not get better
- •
- you have symptoms of heart problems or stroke:
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- chest pain
- •
- trouble breathing
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- weakness in one part or side of body
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- slurred speech
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- leg swelling
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- redness or swelling is present in the painful area
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- any new symptoms appear
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- fever gets worse or lasts more than 3 days
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- you have difficulty swallowing or the caplet feels stuck in your throat
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- you get nervous, dizzy, or sleepless
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- nasal congestion lasts more than 7 days
Directions
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- do not take more than directed
- •
- the smallest effective dose should be used
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- swallow whole; do not crush or chew
- •
- drink a full glass of water with each dose
- •
- adults and children 12 years and older: 1 caplet every 12 hours; do not take more than 2 caplets in 24 hours
- •
- children under 12 years: do not use
Inactive ingredients
Package/Label Principal Display Panel
TopCare® health
COMPARE TO ALEVE-D® SINUS & COLD ACTIVE INGREDIENTS
NON-DROWSY
Sinus & Cold-D
NAPROXEN SODIUM 220 mg
PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg
EXTENDED-RELEASE TABLET
PAIN RELIEVER/FEVER REDUCER (NSAID)
NASAL DECONGESTANT
12 HOUR
MULTI-SYMPTOM RELIEF OF:
• Sinus Pressure
• Nasal Congestion
• Headache
• Body Aches
• Sinus Congestion
1 Caplet – 12 Hours
20 CAPLETS**
** CAPSULE-SHAPED TABLETS
actual size
INGREDIENTS AND APPEARANCE
| TOPCARE SINUS AND COLD D
naproxen sodium, pseudoephedrine hcl tablet, film coated, extended release |
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| Labeler - Topco Associates LLC (006935977) |