Your browser does not support JavaScript! SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [CVS PHARMACY]
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SINUS AND COLD D (naproxen sodium, pseudoephedrine hcl) tablet, film coated
[CVS Pharmacy]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

Active ingredients (in each caplet)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*

Pseudoephedrine HCl 120 mg, extended-release

*nonsteroidal anti-inflammatory drug

Purposes

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

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

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, or kidney disease
you are taking a diuretic
you have problems or serious side effects from taking pain relievers or fever reducers
you have
asthma
diabetes
thyroid disease
trouble urinating due to an enlarged prostate gland

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
the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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
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 22 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

Package/Label Principal Display Panel

Compare to the active ingredients in Aleve-D® Sinus & Cold

NEW!

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 – Headache – Sinus congestion – Nasal congestion – Body aches

1 CAPLET EVERY 12 HOURS

20 CAPLETS†

†CAPSULE-SHAPED TABLETS

Actual Size

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CVS Sinus & Cold 2.jpg
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SINUS AND COLD D 
naproxen sodium, pseudoephedrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-417
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM220 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
POVIDONES 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code L417
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-417-012 in 1 CARTON
110 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07651808/15/2013
Labeler - CVS Pharmacy (062312574)

Revised: 9/2013
 
CVS Pharmacy

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