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34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Purpose
Pain reliever/fever reducer Antihistamine Antitussive Nasal decongestant
Description
Acetaminophen 250 mg Chlorpheniramine Maleate 2 mg Dextromethorphan Hydrobromide 10 mg Phenylephrine HCl 5 mg
Medication Information
Warnings
Liver warning This product contains acetaminophen. Severe liver damage may occur if you take • more than 12 tablets in 24 hours, which is the maximum daily amount • 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.
Uses
temporarily relieves: • muscular aches and pains • headache • temporarily reduces fever • runny nose • sneezing • itching of the nose or throat • itchy, watery eyes due to hay fever or other upper respiratory allergies • pressure • nasal congestion • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
Purpose
Pain reliever/fever reducer
Antihistamine
Antitussive
Nasal decongestant
Directions
• Do not use more than directed (see overdose warning) •do not take this product form more than 10 days unless directed by a doctor • Adults and children 12 years of age and over • take 2 capsule every 4 hours. • Do not take more than 12 capsules in 24 hours Children under 12 years of age • Do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdoes) may cause liver damage. Do not exceed recommended dosage
Other Information
Store at room temperature to 15º-30ºC (59º-86ºF) • do not use if package is torn or damaged
Inactive Ingredients
D&C red no. 33, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, povidone, propylene glycol, purified water
Description
Acetaminophen 250 mg Chlorpheniramine Maleate 2 mg Dextromethorphan Hydrobromide 10 mg Phenylephrine HCl 5 mg
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. • for more than 10 days for pain unless directed by a doctor • for more than 3 days for fever unless directed by a doctor •if you are allergic to acetaminophen or any of the inactive ingredients in this product
• 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 • for persistent or chronic cough such as occurs when smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor • if you are taking sedatives or tranquilizers, without first consulting your doctor.
Package Label
Questions and Comments?
You may report any side effects to 1-855-259-1590 Monday through Friday 9AM-5PM EST
When Using This Product
• excitability may occur, especially in children • may cause drowsiness •alcohol, sedatives and tranquilizers may increase drowsiness effect • use caution when driving a motor vehicle or operating machinery • avoid alcohlic beverages
Stop Use and Aska Doctor
• symptoms do not improve • pain, nasal congestion or cough gets worse or lasts more than 7 days • redness or swelling is present • new symptoms occur •cough comes back or occurs with a rash or a headache tha lasts. These could be the signs of a serious condition • nervousness, dizziness, or sleeplessness occur • fever gets worse or lasts for more than 3 days.
Keep Out of Reach of Children
If pregnant or breast-feeding, ask a health professional before use.
Keep out of the reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
Ask A Doctor Before Use If You Have
• liver disease • a breathing problem such as emphysema • glaucoma • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland
Active Ingredients (in Each Capsule)
Acetaminophen 250 mg
Chlorpheniramine Maleate 2 mg
Dextromethorphan Hydrobromide 10 mg
Phenylephrine HCl 5 mg
Ask A Doctor Or Pharmacist Before Use If You
• are taking the blood thinning drug warfarin
Structured Label Content
Warnings
Liver warning This product contains acetaminophen. Severe liver damage may occur if you take • more than 12 tablets in 24 hours, which is the maximum daily amount • 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.
Uses
temporarily relieves: • muscular aches and pains • headache • temporarily reduces fever • runny nose • sneezing • itching of the nose or throat • itchy, watery eyes due to hay fever or other upper respiratory allergies • pressure • nasal congestion • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
Purpose
Pain reliever/fever reducer
Antihistamine
Antitussive
Nasal decongestant
Directions
• Do not use more than directed (see overdose warning) •do not take this product form more than 10 days unless directed by a doctor • Adults and children 12 years of age and over • take 2 capsule every 4 hours. • Do not take more than 12 capsules in 24 hours Children under 12 years of age • Do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdoes) may cause liver damage. Do not exceed recommended dosage
Other Information (Other information)
Store at room temperature to 15º-30ºC (59º-86ºF) • do not use if package is torn or damaged
Inactive Ingredients (Inactive ingredients)
D&C red no. 33, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, povidone, propylene glycol, purified water
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. • for more than 10 days for pain unless directed by a doctor • for more than 3 days for fever unless directed by a doctor •if you are allergic to acetaminophen or any of the inactive ingredients in this product
• 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 • for persistent or chronic cough such as occurs when smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor • if you are taking sedatives or tranquilizers, without first consulting your doctor.
Package Label
Questions and Comments?
You may report any side effects to 1-855-259-1590 Monday through Friday 9AM-5PM EST
When Using This Product (When using this product)
• excitability may occur, especially in children • may cause drowsiness •alcohol, sedatives and tranquilizers may increase drowsiness effect • use caution when driving a motor vehicle or operating machinery • avoid alcohlic beverages
Stop Use and Aska Doctor (Stop use and aska doctor)
• symptoms do not improve • pain, nasal congestion or cough gets worse or lasts more than 7 days • redness or swelling is present • new symptoms occur •cough comes back or occurs with a rash or a headache tha lasts. These could be the signs of a serious condition • nervousness, dizziness, or sleeplessness occur • fever gets worse or lasts for more than 3 days.
Keep Out of Reach of Children (Keep out of reach of children)
If pregnant or breast-feeding, ask a health professional before use.
Keep out of the reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
• liver disease • a breathing problem such as emphysema • glaucoma • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland
Active Ingredients (in Each Capsule) (Active ingredients (in each capsule))
Acetaminophen 250 mg
Chlorpheniramine Maleate 2 mg
Dextromethorphan Hydrobromide 10 mg
Phenylephrine HCl 5 mg
Ask A Doctor Or Pharmacist Before Use If You (Ask a doctor or pharmacist before use if you)
• are taking the blood thinning drug warfarin
Advanced Ingredient Data
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:04:03.019037 · Updated: 2026-03-14T23:04:28.287489