Leader Sinus and Cold-D

Cardinal Health

Cardinal Health Sinus & Cold-D Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each caplet)
• Purposes
• Leader Sinus and Cold-D Uses
• Warnings
  • Do not use
  • Ask a doctor before use if
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding
• Keep out of reach of children.
• Directions
  • Leader Sinus and Cold-D Other information
• Inactive ingredients
  • Questions or comments?
• Package/Label Principal Display Panel

FULL PRESCRIBING INFORMATION

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

Leader Sinus and Cold-D 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 Aleve-D® Sinus & Cold active ingredients

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

Actual Size

1 Caplet every 12 hours

20 CAPLETS** (** Capsule-Shaped Tablets)