Xl3lqijelactmnphnchlrphnrmindxtrmthrphnphnylphrn
da5b31dd-becd-471a-9392-d0ee4b8f9539
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 250 mg Chlorpheniramine Maleate 2 mg Dextromethorphan Hydrobromide 10 mg Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer Antihistamine Antitussive Nasal decongestant
Medication Information
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
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
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.
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
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
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
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
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
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.
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
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
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
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
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:04:03.019037 · Updated: 2026-03-14T23:04:28.287489