Sedalmex 44-546
f2edfedf-e06e-4d1b-8c2d-732e08ec113c
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 100 mg Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant
Medication Information
Purpose
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Description
Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 100 mg Phenylephrine HCl 5 mg
Uses
- temporarily relieves these symptoms due to the common cold:
- headache
- nasal congestion
- cough
- minor aches and pains
- sore throat
- sinus congestion and pressure
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. 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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Directions
-
do not take more than directed
- adults and children 12 years and over
- take 2 caplets every 4 hours
- do not take more than 10 caplets in 24 hours
- take 2 caplets every 4 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
Other Information
- each caplet contains: sodium 3 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
corn starch, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
Questions Or Comments?
1-888-779-2877
Principal Display Panel
NDC 27854-350-01
Belmora LLC
SEDALMEX XL
flu
Acetaminophen
Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Guaifenesin - Expectorant
Phenylephrine HCl - Nasal Decongestant
24 CAPLETS
Actual Size
Relieves: Fever, Headache, Cough, Sore
Throat, Sinus Pressure & Chest Congestion
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING
Questions or Comments Call.
1-888-779-2877 M-F 9AM-5PM EST
Distributed by Belmora LLC, 3033 Wilson Blvd.
Suite 700, Arlington, VA 22201
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
When Using This Product
do not exceed recommended dosage.
Stop Use and Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- pain, cough, or nasal congestion 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.
If Pregnant Or Breast Feeding,
ask a health professional before use.
Keep Out of Reach of Children.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Active Ingredients (in Each Caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 100 mg
Phenylephrine HCl 5 mg
Ask A Doctor Before Use If You Have
- diabetes
- liver disease
- heart disease
- thyroid disease
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin.
Structured Label Content
Uses
- temporarily relieves these symptoms due to the common cold:
- headache
- nasal congestion
- cough
- minor aches and pains
- sore throat
- sinus congestion and pressure
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- temporarily reduces fever
Purpose
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Warnings
Liver warning: This product contains acetaminophen. 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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Directions
-
do not take more than directed
- adults and children 12 years and over
- take 2 caplets every 4 hours
- do not take more than 10 caplets in 24 hours
- take 2 caplets every 4 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
Other Information (Other information)
- each caplet contains: sodium 3 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)
corn starch, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
Questions Or Comments? (Questions or comments?)
1-888-779-2877
Principal Display Panel (Principal display panel)
NDC 27854-350-01
Belmora LLC
SEDALMEX XL
flu
Acetaminophen
Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Guaifenesin - Expectorant
Phenylephrine HCl - Nasal Decongestant
24 CAPLETS
Actual Size
Relieves: Fever, Headache, Cough, Sore
Throat, Sinus Pressure & Chest Congestion
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING
Questions or Comments Call.
1-888-779-2877 M-F 9AM-5PM EST
Distributed by Belmora LLC, 3033 Wilson Blvd.
Suite 700, Arlington, VA 22201
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
When Using This Product (When using this product)
do not exceed recommended dosage.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
- nervousness, dizziness, or sleeplessness occur
- pain, cough, or nasal congestion 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.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)
ask a health professional before use.
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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 100 mg
Phenylephrine HCl 5 mg
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
- diabetes
- liver disease
- heart disease
- thyroid disease
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
taking the blood thinning drug warfarin.
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Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:42.617958 · Updated: 2026-03-14T23:07:58.892866