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  5. Label Information: All Day Sinus And Cold D

FDA Label for All Day Sinus And Cold D

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH CAPLET)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

All Day Sinus And Cold D Product Label

The following document was submitted to the FDA by the labeler of this product Walgreen Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 Aleve-D® Sinus ε Cold active ingredients

NON-DROWSY

All Day Sinus & Cold D

NAPROXEN SODIUM 220 mg / PSEUDOEPHEDRINE HHYDROCHLORIDE 120 mg

EXTENDED-RELEASE TABLET

PAIN RELIEVER / FEVER REDUCER (NSAID) & NASAL DECONGESTANT

12 HOUR

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

all day sinus & cold D image 1 - image 01

all day sinus & cold D image 1 - image 01


* Please review the disclaimer below.