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Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Doxylamine Succinate

OTC Oral RxCUI 707195
Contents

Overview

Route
Oral
Label date
2025-12-04

Indications and usage

Uses Uses · temporarily relieves these symptoms due to a cold or flu: · minor aches and pains · headache · sore throat · helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive · temporarily reduces fever

USES temporarily relieves these symptoms due to a cold or flu: minor aches and pains · headache · cough sore throat · runny nose · sneezing temporarily reduces fever

Dosage and administration

Directions Directions · do not take more than the recommended dose · do not take the Day and Night products at the same time; wait 4 hours after taking the last Night dose before taking the Day product. · adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 6 capsules in 12 hours or as directed by a doctor. · children under 12 years of age: do not use

Directions · do not take more than the recommended dose · do not take the Day and Night products at the same time; wait 4 hours after taking the last Day dose before taking the Night product. · adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 4 capsules in 12 hours or as directed by a doctor. · children under 12 years of age: do not use

Warnings

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 or severe allergic reactions. Symptoms may include: · skin reddening · blisters · rash · hives · facial swelling · asthma (wheezing) · shock If a skin or general allergic 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 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 have ever had an allergic reaction to this product or any of its ingredients
  • in children under 12 years of age Aska a doctor Ask a doctor before use if you have
  • liver disease
  • persistent or chronic cough such as occurs with smoking, asthma,chronic bronchitis, or emphysema
  • cough that occurs with excess phelgm Ask a doctor or pharmacist Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use Stop use and ask a doctor if · pain 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. 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Liver Warning 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 or severe allergic reactions. Symptoms may include: · skin reddening · blisters · rash · hives · facial swelling · asthma (wheezing) · shock If a skin or general allergic 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

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 have ever had an allergic reaction to this product or any of its ingredients
  • in children under 12 years of age

to sedate children 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
  • in children under 12 years of age

Ask a doctor before use if

Aska a doctor Ask a doctor before use if you have

  • liver disease
  • persistent or chronic cough such as occurs with smoking, asthma,chronic bronchitis, or emphysema
  • cough that occurs with excess phelgm

Ask a doctor or pharmacist before use if

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

Ask a doctor before use if you have

  • liver disease
  • glaucoma
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with excessive phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

this product

  • may cause marked drowsiness
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if

Stop use and ask a doctor if · pain 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.

and ask a doctor if · pain 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

Pregnancy or breast-feeding

If pregnant 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 Active ingredients (in each capsule) Purposes Acetaminophen 325 mg…………….………..Pain reliever/fever reducer Guaifenesin 200 mg…………………………………………...Expectorant

s (in each capsule)Purposes Acetaminophen 325 mg…………….………...Pain reliever/fever reducer Dextromethorphan hydrobromide 10 mg……………Cough suppressant Doxylamine succinate 6.25 mg……………………………...Antihistamine

Inactive ingredients

Inactive ingrediens Inactive ingredients FD&C Yellow#6, gelatin, glycerin, iron oxide black, lecithin, medium-chain triglycerides, mica, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

s D&C yellow No.10, FD&C blue No.1, gelatin, glycerin, lecithin, medium-chain triglycerides, silica, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, soybean oil, titanium dioxide

Keep out of reach of children

of children Keep out of reach of children. 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 notice any signs or symptoms.

of children . 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 notice any signs or symptoms.