sudafed pe head congestion + pain
76513fb2-7323-4f1f-8a10-92f8f603cf97
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Medication Information
Uses
- temporarily relieves these symptoms associated with the common cold or flu:
- headache
- fever
- sinus pressure
- nasal congestion
- minor body aches and pains
- reduces swelling of the nasal passages
- temporarily restores freer breathing through the nose
Directions
- do not take more than directed
- adults and children 12 years of age and over:
- take 1 caplet every 4 hours while symptoms persist
- do not use more than 6 caplets in any 24-hour period unless directed by a doctor
- children under 12 years of age: do not use because this product contains too much medication for children under this age
Other Information
- store between 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
- read all warnings and directions before use. Keep carton.
- do not use if blister unit is torn or broken
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, stearic acid, talc, titanium dioxide
Description
Drug Facts
Principal Display Panel
NDC 50580-436-01
SUDAFED PE®
HEAD CONGESTION
+ PAIN
Ibuprofen 200 mg, Phenylephrine Hydrochloride 10 mg Tablets
Pain Reliever/Fever Reducer (NSAID),
Nasal Decongestant
• NASAL CONGESTION • HEADACHE
• SINUS PRESSURE • FEVER
• NASAL SWELLING • BODY ACHES
ONE CAPLET DOSE!
actual size
20 COATED CAPLETS**
**CAPSULE-SHAPED TABLETS
NON-DROWSY
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. (1-800-222-1222)
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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
| Active ingredients (in each caplet) | Purposes |
|---|---|
| Ibuprofen 200 mg (NSAID)
nonsteroidal anti-inflammatory drug
|
Pain reliever/fever reducer |
| Phenylephrine HCl 10 mg | Nasal decongestant |
Do Not Use
- in children under 12 years of age because this product contains too much medication for children under this age
- 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
Allergy Alert
Ibuprofen 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.
Questions Or Comments?
call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)
When Using This Product
- take with food or milk if stomach upset occurs
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
Ask A Doctor Before Use If
- stomach bleeding warning applies to you
- you have problems or serious side effects from taking pain relievers or fever reducers
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke
- you are taking a diuretic
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
- pain gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- nasal congestion lasts for more than 7 days
- symptoms continue or get worse
- redness or swelling is present in the painful area
- you get nervous, dizzy, or sleepless
- any new symptoms appear
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.
Ask A Doctor Or Pharmacist Before Use If You Are
- under a doctor's care for any serious condition
- taking any other product that contains phenylephrine or any other nasal decongestant
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- taking any other drug
Structured Label Content
Uses
- temporarily relieves these symptoms associated with the common cold or flu:
- headache
- fever
- sinus pressure
- nasal congestion
- minor body aches and pains
- reduces swelling of the nasal passages
- temporarily restores freer breathing through the nose
Directions
- do not take more than directed
- adults and children 12 years of age and over:
- take 1 caplet every 4 hours while symptoms persist
- do not use more than 6 caplets in any 24-hour period unless directed by a doctor
- children under 12 years of age: do not use because this product contains too much medication for children under this age
Other Information (Other information)
- store between 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
- read all warnings and directions before use. Keep carton.
- do not use if blister unit is torn or broken
Inactive Ingredients (Inactive ingredients)
colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, stearic acid, talc, titanium dioxide
Principal Display Panel (PRINCIPAL DISPLAY PANEL)
NDC 50580-436-01
SUDAFED PE®
HEAD CONGESTION
+ PAIN
Ibuprofen 200 mg, Phenylephrine Hydrochloride 10 mg Tablets
Pain Reliever/Fever Reducer (NSAID),
Nasal Decongestant
• NASAL CONGESTION • HEADACHE
• SINUS PRESSURE • FEVER
• NASAL SWELLING • BODY ACHES
ONE CAPLET DOSE!
actual size
20 COATED CAPLETS**
**CAPSULE-SHAPED TABLETS
NON-DROWSY
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. (1-800-222-1222)
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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)
| Active ingredients (in each caplet) | Purposes |
|---|---|
| Ibuprofen 200 mg (NSAID)
nonsteroidal anti-inflammatory drug
|
Pain reliever/fever reducer |
| Phenylephrine HCl 10 mg | Nasal decongestant |
Do Not Use (Do not use)
- in children under 12 years of age because this product contains too much medication for children under this age
- 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
Allergy Alert (Allergy alert)
Ibuprofen 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.
Questions Or Comments? (Questions or comments?)
call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)
When Using This Product (When using this product)
- take with food or milk if stomach upset occurs
Stomach Bleeding Warning (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
Ask A Doctor Before Use If (Ask a doctor before use if)
- stomach bleeding warning applies to you
- you have problems or serious side effects from taking pain relievers or fever reducers
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke
- you are taking a diuretic
Stop Use and Ask A Doctor If (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
- pain gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- nasal congestion lasts for more than 7 days
- symptoms continue or get worse
- redness or swelling is present in the painful area
- you get nervous, dizzy, or sleepless
- any new symptoms appear
Heart Attack and Stroke Warning (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.
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
- under a doctor's care for any serious condition
- taking any other product that contains phenylephrine or any other nasal decongestant
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- taking any other drug
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Source: dailymed · Ingested: 2026-02-15T12:05:42.445873 · Updated: 2026-03-14T23:07:53.934759