Overnight Cold and Flu

Overnight Cold and Flu is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL. It is labelled by RARITAN PHARMACEUTICALS taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 68163-698, application M012, label effective 20260908. It is one of 8 FDA drug label records sharing the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE 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, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL are most often described in connection with: temporarily relieves, common cold, flu symptoms, cough minor, pains sore, throat headache, runny nose, sneezing itching. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses ▪ temporarily relieves these common cold and flu symptoms: ▪ cough ▪ minor aches and pains ▪ sore throat ▪ headache ▪ runny nose ▪ sneezing ▪ itching of the nose or throat ▪ itchy, watery eyes due to hay fever ▪ temporarily reduces fever ▪ controls cough to help you get to sleep

Directions ▪ do not take more than directed (see Overdose warning ) ▪ do not take more than 4 doses in any 24-hour period ▪ measure only with dosing cup provided ▪ do not use dosing cup with other products ▪ dose as follows or as directed by a doctor ▪ adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours ▪ children under 12 years of age: do not use

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take: ▪ more than 4000 mg in 24 hours, which is the maximum daily amount ▪ with other drugs containing acetaminophen ▪ 3 or more alcoholic drinks daily 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 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 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 ▪ glaucoma ▪ trouble urinating due to an enlarged prostate gland ▪ a breathing problem such as emphysema or chronic bronchitis ▪ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ▪ cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are ▪ taking the blood thinning drug warfarin ▪ taking sedatives or tranquilizers When using this product ▪ do not use more than directed ▪ excitability may occur, especially in children ▪ marked drowsiness may occur ▪ alcohol, sedatives, and tranquilizers may increase drowsiness ▪ avoid alcoholic drinks ▪ use caution when driving a motor vehicle or operating machinery 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 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 (overdose) may cause liver damage. 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.

FDA lists 8 drug label records with ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE 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.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Overnight Cold and Flu used for?
Uses ▪ temporarily relieves these common cold and flu symptoms: ▪ cough ▪ minor aches and pains ▪ sore throat ▪ headache ▪ runny nose ▪ sneezing ▪ itching of the nose or throat ▪ itchy, watery eyes due to hay fever ▪ temporarily reduces fever ▪ controls cough to help you get to sleep

Who makes Overnight Cold and Flu?
RARITAN PHARMACEUTICALS is the labeler of record for Overnight Cold and Flu. 8 FDA label records share the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE 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 Overnight Cold and Flu 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 Overnight Cold and Flu 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, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL?
Yes. 8 FDA drug label records list ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE 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 Overnight Cold and Flu been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.