LEADER ALL DAY SINUS AND COLD D- naproxen sodium, pseudoephedrine hcl tablet, film coated, extended release 
Cardinal Health 110, LLC. dba Leader

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Cardinal Health All Day Sinus & Cold-D 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

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

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

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, 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 aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
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 at 20 weeks or later in 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
meets USP Dissolution Test 2
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

LEADER

Non-Drowsy

All Day 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

Actual Size

COMPARE TO ALEVE-D® SINUS & COLD active ingredients

1 Caplet – 12 Hours

100% Money Back Guarantee

20 CAPLETS**

**Capsule-Shaped Tablets

417-e9-all-day-sinus-and-cold-d
LEADER ALL DAY SINUS AND COLD D 
naproxen sodium, pseudoephedrine hcl tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0605
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScoreno score
ShapeOVALSize18mm
FlavorImprint Code L417
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0605-120 in 1 CARTON05/19/2022
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07651805/19/2022
Labeler - Cardinal Health 110, LLC. dba Leader (063997360)

Revised: 4/2024
Document Id: ff54f0d6-67e0-40e6-9514-45b0abfbb764
Set id: 83f7cfbb-ab84-4594-ae7a-4a657385c8a7
Version: 2
Effective Time: 20240412
 
Cardinal Health 110, LLC. dba Leader