ALEVE-D SINUS AND HEADACHE- naproxen sodium, pseudoephedrine hydrochloride tablet

Aleve-D Sinus and Headache by

Drug Labeling and Warnings

Aleve-D Sinus and Headache by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients

(in each caplet)

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

Pseudoephedrine HCl 120 mg,

*nonsteroidal anti-inflammatory drug

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

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

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 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,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 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

WHEN USING

When using this product

take with food or milk if stomach upset occurs

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

●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

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.

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 21 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

QUESTIONS

Questions or comments?

1-800-986-0369

(Mon – Fri 9AM – 5PM EST)

PRINCIPAL DISPLAY PANEL

See New Warnings

NON-DROWSY

ALL DAY STRONG®

ALEVE-D®

SINUS & HEADACHE

Naproxen sodium 220 mg (NSAID)

Pseudoephedrine HCl 120 mg extended-release tablets

Pain reliever-fever reducer/nasal decongestant

12 HOUR MULTI-SYMPTOM RELIEF OF

SINUS PRESSURE

HEADACE · SINUS CONGESTION

NASAL CONGESTION

actual size

1 CAPLET - 12 HOURS

10 CAPLETS

CAPSULE-SHAPED TABLETS

INGREDIENTS AND APPEARANCE

ALEVE-D SINUS AND HEADACHE 
naproxen sodium, pseudoephedrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-6045
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)	NAPROXEN SODIUM	220 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	120 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL (Oblong)	Size	17mm
Flavor		Imprint Code	Aleve;D
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0280-6045-10	1 in 1 CARTON	01/01/2014
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076518	01/01/2014

Labeler - Bayer HealthCare LLC. (112117283)