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Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, and Doxylamine Succinate

OTC RxCUI 1043400
Contents

Overview

Label date
2024-10-22

Indications and usage

Uses Temporarily relieves these common cold and flu symptoms minor aches and pain headache sore throat nasal congestion cough due to minor throat and bronchial irritation temporarily reduces fever

Uses Temporarily relieves these common cold and flu symptoms: sore throat headache minor aches and pain runny nose and sneezing cough due to minor throat and bronchial irritation temporarily reduces rever

Purpose

Active Ingredients (in each 30 mL) Purpose Acetaminophen 650 mg Pain reliever/Fever reducer Dextromethorphan HBr 20 mg Cough suppressant Phenylephrine HCl 10 mg Nasal Decongestant

Active Ingredients (in each 30 mL) Purpose Acetaminophen 650 mg Pain reliever/Fever reducer Dextromethorphan HBr 30 mg Cough suppressant Doxylamine Succinate 12.5 mg Antihistamine

Dosage and administration

Directions do not take more than directed do not take more than 4 doses in any 24 hours this adult strength product is not intended for use in children under 12 years of age measure only with dosing cup provided keep dosing cup with product mL = mililiter TBSP = tablespoon dose as follows Adults and children 12 years or age and over 30 mL (2 tablespoons) every 4 hours Children under 12 years Do not use When using Day Time and Night Time products, carefully read each label to ensure correct dosing.

Directions do not take more than directed do not take more than 4 doses in any 24 hours this adult strength product is not intended for use in children under 12 year of age measure only with dosing cup provided keep dosing cup with product mL = mililiter TBSP = tablespoon dose as follows Adults and children 12 years of age and over 30 mL (2 tablespoons) every 6 hours Children under 12 years of age Do not use when using day time and night time products, carefully read each label to ensure correct dosing

Warnings

Liver warning The product contains Acetaminophen. Severe liver damage may occur if you take more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product 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 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. 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 two 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. Ask a doctor before use if you have liver disease heart disease thyroid disease diabetes high blood pressure trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma or emphysema cough accompanied by excessive phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not use more than directed (see overdose warning) avoid alcoholic drinks Stop use and ask a doctor if you get nervous, dizzy or sleepless fever gets worse or lasts more than 3 days pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) redness or swelling is present cough comes back, or occurs with rash or headache that lasts. new symptoms occur 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. 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 right away. Prompt medical attention is critical for adults as well as for children even if you do not noticve any signs or symptoms.

Liver warning The product contains Acetaminophen. Severe liver damage may occur if you take more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product 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 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. 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 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. to make a child sleepy Ask a doctor before use if you have liver disease glaucoma; cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to an enlarged prostate gland. Ask a doctor or pharmacist before use if you are taking sedatives or tranquillizers if you are taking the blood thinning drug warfarin When using this product do not use more than directed avoid alcoholic drinks excitability may occur, especially in children, marked drowsiness may occur be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if redness or swelling is present symptoms do not get better within 7 days or are accompanied by a fever fever gets worse or lasts more than 3 days new symptoms occur cough lasts more than 7 days, comes back, or occurs with fever, 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. Overdose warning Taking more than the recommended dose may cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not noticve any signs or symptoms.

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 two 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.

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 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. to make a child sleepy

Ask a doctor before use if

Ask a doctor before use if you have liver disease heart disease thyroid disease diabetes high blood pressure trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma or emphysema cough accompanied by excessive phlegm (mucus)

Ask a doctor before use if you have liver disease glaucoma; cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to an enlarged prostate gland.

Ask a doctor or pharmacist before use if

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

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

When using this product

this product do not use more than directed (see overdose warning) avoid alcoholic drinks

this product do not use more than directed avoid alcoholic drinks excitability may occur, especially in children, marked drowsiness may occur be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

and ask a doctor if you get nervous, dizzy or sleepless fever gets worse or lasts more than 3 days pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) redness or swelling is present cough comes back, or occurs with rash or headache that lasts. new symptoms occur These could be signs of a serious condition.

and ask a doctor if redness or swelling is present symptoms do not get better within 7 days or are accompanied by a fever fever gets worse or lasts more than 3 days new symptoms occur cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

Pregnancy or breast-feeding

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

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

Active ingredient (label)

s (in each 30 mL) Purpose Acetaminophen 650 mg Pain reliever/Fever reducer Dextromethorphan HBr 20 mg Cough suppressant Phenylephrine HCl 10 mg Nasal Decongestant

s (in each 30 mL) Purpose Acetaminophen 650 mg Pain reliever/Fever reducer Dextromethorphan HBr 30 mg Cough suppressant Doxylamine Succinate 12.5 mg Antihistamine

Inactive ingredients

s Citric acid, FD&C Yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

s Citric acid, FD&C Yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Storage and handling

Other information Each 30 mL contains sodium: 18 mg store between 15-30 o C (59-86 o F) do not refrigerate

Other information Each 30 mL contains sodium 18 mg store between 15-30 o C (59-86 o F) do not refrigerate

Keep out of reach of children

of children.

of children.