Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl

Capsule, Liquid Filled · Oral

Over the counter Expectorant Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist

Active ingredient

Acetaminophen 325mg Dextromethorphan HBr 10mg Guaifenesin 200mg Phenylephrine HCl 5mg

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Uses

Temporarily relieves common cold/flu symptoms: Nasal congestion Sinus congestion & pressure Cough due to minor throat & bronchial irritation Minor aches & pain Headache Fever Sore throat Reduces swelling of nasal passages Temporarily restore freer breathing through the nose Promotes nasal and/or sinus drainage Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amount for this product with other drugs contains 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 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 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. Ask a doctor before use if you have: Liver disease High blood pressure Thyroid disease Diabetes Trouble urinating due to enlarged 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. When using this product, do not use more than directed. Stop use and ask a doctor if: You get nervous, dizzy, or sleepless Pain, nasal congestion, or cough gets worse or lasts more than 7 days Fever gets worse or last 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.

Keep out of reach of children

Keep out of reach of children.

Directions

Take only as directed (See overdose warning) Do not exceed 4 doses per 24-hours Adults and children 12 years and over: take 2 softgels with water every 4 hours Children 4 to under 12 years: ask a doctor When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

Inactive ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Label text from the FDA structured product label by OPMX LLC (revised May 17, 2024). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl NDC products (1)

NDCStrength & formLabelerType
69729-782Acetaminophen 325 mg/1; Guaifenesin 200 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Phenylephrine Hydrochloride 5 mg/1
Capsule, Liquid Filled
OPMX LLCOTC MONOGRAPH DRUG

Frequently asked questions

What is Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl used for?

Temporarily relieves common cold/flu symptoms: Nasal congestion Sinus congestion & pressure Cough due to minor throat & bronchial irritation Minor aches & pain Headache Fever Sore throat Reduces swelling of nasal passages Temporarily restore freer breathing through the nose Promotes nasal and/or sinus drainage Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial…

Who makes Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl?

Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl is listed by 1 labeler in the FDA NDC directory, including OPMX LLC.