Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl

Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL. It is labelled by OPMX LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 69729-322, application M012, label effective 20220311. It is one of 4 FDA drug label records sharing the active ingredient ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL are most often described in connection with: temporarily relieves, symptoms hay, respiratory allergies, headache nasal, congestion sinus, pressure runny, sneezing minor, aches pain. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Temporarily relieves these symptoms of hay fever or other respiratory allergies: Headache Nasal congestion Sinus congestion & pressure Runny nose and sneezing Minor aches & pain Temporarily relieves these additional symptoms of hay fever: itching of the nose or throat itchy, watery eyes helps clear nasal passages helps decongest sinus opening and passages

Do not take more than directed - see overdose warning swallow whole; do not crush, chew or dissolve do not exceed 6 tablets per 24 hours Adults and children 12 years of age & over 1 tablet with water every 4-6 hours as needed Children 4 to 12 years of age Ask a doctor Children under 4 years of age Do not use

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take : more than 6 tablets 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 A breathing problem such as emphysema or chronic bronchitis 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 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.

FDA lists 4 drug label records with ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl used for?
Temporarily relieves these symptoms of hay fever or other respiratory allergies: Headache Nasal congestion Sinus congestion & pressure Runny nose and sneezing Minor aches & pain Temporarily relieves these additional symptoms of hay fever: itching of the nose or throat itchy, watery eyes helps clear nasal passages helps decongest sinus opening and passages

Who makes Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl?
OPMX LLC is the labeler of record for Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl. 4 FDA label records share the active ingredient ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL?
Yes. 4 FDA drug label records list ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.