Aleve-d Sinus & Headache
5ab980c0-c48a-233b-e053-2991aa0a4fd1
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Medication Information
Warnings and Precautions
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.
Indications and 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
Dosage and 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
Description
Drug Facts
Section 42229-5
Drug Facts
Section 50565-1
Keep out of reach of children. In case of overdose, get
medical help or contact a Poison Control Center right away.
Section 50566-9
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
Section 50567-7
When using this product
• take with food or milk if stomach upset occurs
Section 50568-5
Ask a doctor or pharmacist before use if you are
• under a doctor’s care for any serious condition
• taking any other drug
Section 50569-3
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
Section 50570-1
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
Section 51727-6
Inactive ingredients colloidal silicon dioxide,
hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, polysorbate 80,
povidone, talc, titanium dioxide
Section 51945-4
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
Section 53413-1
Questions or comments?
1-800-986-0369
(Mon – Fri 9AM – 5PM EST)
Section 53414-9
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.
Section 55105-1
Purposes
Pain reliever/fever reducer
Nasal decongestant
Section 55106-9
Active ingredients
(in each caplet)
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
Pseudoephedrine HCl 120 mg,
*nonsteroidal anti-inflammatory drug
Other Information
Other information
• each caplet contains: sodium 21 mg • store at 20-25°C (68-77°F) • store in a dry place
Structured Label Content
Indications and Usage (34067-9)
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
Dosage and Administration (34068-7)
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
Warnings and Precautions (34071-1)
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.
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
Keep out of reach of children. In case of overdose, get
medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
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
Section 50567-7 (50567-7)
When using this product
• take with food or milk if stomach upset occurs
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are
• under a doctor’s care for any serious condition
• taking any other drug
Section 50569-3 (50569-3)
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
Section 50570-1 (50570-1)
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
Section 51727-6 (51727-6)
Inactive ingredients colloidal silicon dioxide,
hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, polysorbate 80,
povidone, talc, titanium dioxide
Section 51945-4 (51945-4)
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
Section 53413-1 (53413-1)
Questions or comments?
1-800-986-0369
(Mon – Fri 9AM – 5PM EST)
Section 53414-9 (53414-9)
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.
Section 55105-1 (55105-1)
Purposes
Pain reliever/fever reducer
Nasal decongestant
Section 55106-9 (55106-9)
Active ingredients
(in each caplet)
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
Pseudoephedrine HCl 120 mg,
*nonsteroidal anti-inflammatory drug
Other Information
Other information
• each caplet contains: sodium 21 mg • store at 20-25°C (68-77°F) • store in a dry place
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:28.171408 · Updated: 2026-03-14T23:10:57.415546