Label: TOPCARE SINUS AND COLD D- naproxen sodium, pseudoephedrine hcl tablet, film coated, extended release
- NDC Code(s): 36800-417-01, 36800-417-52
- Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 17, 2025
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each caplet)
- Purposes
- Uses
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Warnings
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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- hives
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- facial swelling
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- asthma (wheezing)
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- shock
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- skin reddening
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- 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
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- 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
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- 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.
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- in children under 12 years of age
Ask a doctor before use if
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- 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
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- you are taking a diuretic
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- you have problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use if you are
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- under a doctor’s care for any serious condition
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- taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
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- taking any other drug
Stop use and ask a doctor if
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- you experience any of the following signs of stomach bleeding:
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- feel faint
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- vomit blood
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- have bloody or black stools
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- have stomach pain that does not get better
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- you have symptoms of heart problems or stroke:
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- chest pain
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- 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
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Directions
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- do not take more than directed
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- the smallest effective dose should be used
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- swallow whole; do not crush or chew
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- drink a full glass of water with each dose
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- adults and children 12 years and older: 1 caplet every 12 hours; do not take more than 2 caplets in 24 hours
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- children under 12 years: do not use
- Other information
- Inactive ingredients
- Questions or comments?
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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
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INGREDIENTS AND APPEARANCE
TOPCARE SINUS AND COLD D
naproxen sodium, pseudoephedrine hcl tablet, film coated, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-417 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM 220 mg PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape OVAL Size 18mm Flavor Imprint Code L417 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-417-52 10 in 1 CARTON 08/14/2013 03/20/2018 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:36800-417-01 20 in 1 CARTON 08/14/2013 2 1 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 ANDA076518 08/14/2013 Labeler - Topco Associates LLC (006935977)
