Label: NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE COLD AND SINUS- naproxen sodium and pseudoephedrine hydrochloride tablet, extended release
- NDC Code(s): 71179-816-24
- Packager: VESPYR BRANDS, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 8, 2024
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- 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:
- 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.
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Do not use
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
- in children under 12 years of age
- 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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Ask a doctor before use if
- the stomach bleeding warning applies to you
- 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
- you have problems or serious side effects from taking pain relievers or fever reducers
- Ask a doctor or pharmacist before use if you are
- When using this product
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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
- redness or swelling is present in the painful area
- any new symptoms appear
- fever gets worse or lasts more than 3 days
- you have difficulty swallowing or the caplet feels stuck in your throat
- you get nervous, dizzy, or sleepless
- nasal congestion lasts more than 7 days
- you experience any of the following signs of stomach bleeding:
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 220 mg / 120 mg 24 Caplets (Capsule-Shaped Tablets) Blister Carton Label
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INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE COLD AND SINUS
naproxen sodium and pseudoephedrine hydrochloride tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71179-816 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) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) POVIDONE K30 (UNII: U725QWY32X) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (White to off-white) Score no score Shape CAPSULE (Modified Capsule Shaped) Size 17mm Flavor Imprint Code L95 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71179-816-24 3 in 1 CARTON 08/07/2024 1 8 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 ANDA211360 08/07/2024 Labeler - VESPYR BRANDS, INC. (118094893) Registrant - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations APL HEALTHCARE LIMITED 650918514 ANALYSIS(71179-816) , MANUFACTURE(71179-816)