VICKS SINEX D SEVERE SINUS AND COLD- acetaminophen, phenylephrine hydrochloride, doxylamine succinate, and dextromethorphan hydrobromide tablet

Vicks Sinex D by

Drug Labeling and Warnings

Vicks Sinex D by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each caplet)

Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
Pseudoephedrine HCl 120 mg,
extended-release
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer
Nasal decongestant

Uses

temporarily relieves these cold, sinus, and flu symptoms:

• sinus pressure
• minor body aches and pains
• headache
• nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose)
• fever

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

When using this product

• take with food or milk if stomach upset occurs

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

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

• do not take more than directed
• the smallest effective dose should be used
• 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

Other information

• each caplet contains: sodium 21 mg
• store at 20-25°C (68 -77°F)
• store in a dry place

Inactive ingredients

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide

Questions or comments?

1-800-719-9260

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble,
Cincinnati OH 45202

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 HOUR

MULTI-SYMPTOM RELIEF OF:
Sinus Pressure, Headache,
Sinus Congestion,
Nasal Congestion & Body Aches

See New Warnings

1 caplet-12 hours

Non-Drowsy

**Capsule-Shaped Tablets

30 CAPLETS

INGREDIENTS AND APPEARANCE

VICKS SINEX D  SEVERE SINUS AND COLD
acetaminophen, phenylephrine hydrochloride, doxylamine succinate, and dextromethorphan hydrobromide tablet

Product 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)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
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

Labeler - The Procter & Gamble Manufacturing Company (004238200)