Sudafed Pe Head Congestion + Mucus

SPL v8

SPL

SPL Set ID f0739186-41b9-4761-adf7-08101b30a18e

Route

ORAL

Published

Effective Date 2020-08-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg) Guaifenesin (200 mg) Phenylephrine (5 mg)

Inactive Ingredients

Carnauba Wax Croscarmellose Sodium Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance

Imprint: SUPE;SU02 Shape: oval Color: white Size: 20 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-06-17

Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
- sinus congestion and pressure
- headache
- minor aches and pains
- nasal congestion
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily reduces fever

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product do not exceed recommended dose

Section 50568-5

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Active ingredients (in each tablet)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestant

Directions

do not take more than directed (see overdose warning)

adults and children 12 years and over	take 2 tablets every 4 hours do not take more than 10 tablets in 24 hours
children under 12 years	ask a doctor

Do Not Use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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.
if you have ever had an allergic reaction to this product or any of its ingredients

Liver Warning

This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information

each tablet contains: sodium 3 mg
store between 20-25°C (68-77°F)
do not use if blister unit is torn or broken

Inactive Ingredients

carnauba wax, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide, triacetin

Questions Or Comments?

call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)

Principal Display Panel

PREVIOUSLY SUDAFED PE ^® PRESSURE+PAIN+MUCUS

NDC 50580-447-01

SUDAFED ^PE®

HEAD CONGESTION

+ MUCUS

Acetaminophen, Guaifenesin, Phenylephrine HCl,

Pain Reliever/Fever Reducer, Expectorant, Nasal Decongestant

actual

size

SINUS PRESSURE
HEADACHE
CHEST CONGESTION

24 TABLETS

NON-DROWSY

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
pain, nasal congestion or cough gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

Ask A Doctor Before Use If You Have

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough that occurs with too much phlegm (mucus)

Structured Label Content

Uses

temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
- sinus congestion and pressure
- headache
- minor aches and pains
- nasal congestion
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily reduces fever

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product do not exceed recommended dose

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Active ingredients (in each tablet)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestant

Directions

do not take more than directed (see overdose warning)

adults and children 12 years and over	take 2 tablets every 4 hours do not take more than 10 tablets in 24 hours
children under 12 years	ask a doctor

Do Not Use (Do not use)

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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.
if you have ever had an allergic reaction to this product or any of its ingredients

Liver Warning (Liver warning)

This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Overdose Warning (Overdose warning)

Other Information (Other information)

each tablet contains: sodium 3 mg
store between 20-25°C (68-77°F)
do not use if blister unit is torn or broken

Inactive Ingredients (Inactive ingredients)

carnauba wax, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide, triacetin

Questions Or Comments? (Questions or comments?)

call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

PREVIOUSLY SUDAFED PE ^® PRESSURE+PAIN+MUCUS

NDC 50580-447-01

SUDAFED ^PE®

HEAD CONGESTION

+ MUCUS

Acetaminophen, Guaifenesin, Phenylephrine HCl,

Pain Reliever/Fever Reducer, Expectorant, Nasal Decongestant

actual

size

SINUS PRESSURE
HEADACHE
CHEST CONGESTION

24 TABLETS

NON-DROWSY

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

nervousness, dizziness, or sleeplessness occur
pain, nasal congestion or cough gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough that occurs with too much phlegm (mucus)

Advanced Ingredient Data

[{"name": "CARNAUBA WAX", "unii": "R12CBM0EIZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL CELLULOSE, UNSPECIFIED", "unii": "9XZ8H6N6OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIACETIN", "unii": "XHX3C3X673", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "325", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: sinus congestion and pressure headache minor aches and pains nasal congestion helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily reduces fever", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "50567-7": "When using this product do not exceed recommended dose", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each tablet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant", "Directions": "do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 tablets every 4 hours do not take more than 10 tablets in 24 hours children under 12 years ask a doctor", "Do not use": "with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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. if you have ever had an allergic reaction to this product or any of its ingredients", "Liver warning": "This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product", "Overdose warning": "In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Other information": "each tablet contains: sodium 3 mg store between 20-25°C (68-77°F) do not use if blister unit is torn or broken", "Inactive ingredients": "carnauba wax, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide, triacetin", "Questions or comments?": "call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)", "PRINCIPAL DISPLAY PANEL": "PREVIOUSLY SUDAFED PE ® PRESSURE+PAIN+MUCUS NDC 50580-447-01 SUDAFED PE® HEAD CONGESTION + MUCUS Acetaminophen, Guaifenesin, Phenylephrine HCl, Pain Reliever/Fever Reducer, Expectorant, Nasal Decongestant actual size SINUS PRESSURE HEADACHE CHEST CONGESTION 24 TABLETS NON-DROWSY", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur pain, nasal congestion or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition.", "Ask a doctor before use if you have": "liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:21.748107 · Updated: 2026-03-14T23:05:02.267888