NDC | 37000-921-30 |
Set ID | 7d3ee6a9-e482-af6a-e053-2a91aa0a64d6 |
Category | HUMAN OTC DRUG LABEL |
Packager | The Procter & Gamble Manufacturing Company |
Generic Name | |
Product Class | alpha-Adrenergic Agonist |
Product Number | |
Application Number | ANDA076518 |
- SPL UNCLASSIFIED SECTION
- 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)
- 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 usemore than directed or for longer than directed.
Do not use
- 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.
- in children under 12 years of age
Ask a doctor before use if you
- 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
- under a doctor's care for any serious condition
- 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
- 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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 30 Caplet Blister Pack Carton
VICKS ®
Sinex ™ D
SEVERE
Sinus & COLD
Naproxen sodium 220 mg and Pseudoephedrine hydrochloride 120 mg extended-release tablet
Pain Reliever/Fever Reducer (NSAID) and Nasal Decongestant
12 HOURMULTI-SYMPTOM RELIEF OF:
Sinus Pressure, Headache,
Sinus Congestion,
Nasal Congestion & Body AchesSee New Warnings
1 caplet-12 hours
Non-Drowsy
**Capsule-Shaped Tablets
30 CAPLETS
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INGREDIENTS AND APPEARANCE
VICKS SINEX D SEVERE SINUS AND COLD
acetaminophen, phenylephrine hydrochloride, doxylamine succinate, and dextromethorphan hydrobromide tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-921 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM 220 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYSORBATE 80 (UNII: 6OZP39ZG8H) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape CAPSULE Size 17mm Flavor Imprint Code L417 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-921-30 3 in 1 CARTON 12/17/2018 1 10 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 12/17/2018 03/01/2021 Labeler - The Procter & Gamble Manufacturing Company (004238200)