FDA Label for Aleve-d Sinus And Headache
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Aleve-d Sinus And Headache Product Label
The following document was submitted to the FDA by the labeler of this product Bayer Healthcare Llc.. 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.
Other
Drug Facts
Otc - Active Ingredient
Active ingredients
(in each caplet)
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
Pseudoephedrine HCl 120 mg,
*nonsteroidal anti-inflammatory drug
Otc - Purpose
Purposes
Pain reliever/fever reducer
Nasal decongestant
Indications & Usage
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
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
Otc - Do Not Use
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
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
• under a doctor’s care for any serious condition
• taking any other drug
Otc - When Using
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
Otc - Stop Use
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
Otc - Pregnancy Or Breast Feeding
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get
medical help or contact a Poison Control Center right away.
Dosage & Administration
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
Other information
• each caplet contains: sodium 22 mg • store at 20-25°C (68-77°F) • store in a dry place
Inactive Ingredient
Inactive ingredients colloidal silicon dioxide,
hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, polysorbate 80,
povidone, talc, titanium dioxide
Otc - Questions
Questions or comments? 1-800-986-0369
(Mon – Fri 9AM – 5PM EST)
* Please review the disclaimer below.