Cold and Flu Relief Daytime
Cold and Flu Relief Daytime is an FDA drug label for the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE manufactured by Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231010.
- Generic name
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
- Manufacturer
- Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 55910-366
- Application
- M012
- Label effective
- 20231010
Active ingredients
Indications & Usage
Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat fever nasal congestion cough due to minor throat and bronchial irritation
Dosage & Administration
Directions do not take more than directed (see overdose warning) do not exceed 4 doses in any 24 hour period measure only with dosing cup provided. Do not use any other dosing device keep dosing cup with product mL=milliliter adults and children 12 years and over 30 mL every 4 hours children 6 to under 12 years 15 mL every 4 hours children 4 to under 6 years ask a doctor children under 4 years do not use When using Day Time and Night Time products, carefully read each label to ensure correct dosing
Contraindications
Not available.
Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: adult take more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount child take more than 4 doses (15 mL each) in 24 hours take with other drugs containing acetaminophen adult has 3 or more alcoholic drinks everyday while using this product Allery 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 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. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if the user has liver disease heart disease high blood pressure thyroid disease diabetes a sodium-restricted diet persistent or chronic cough such as occurs with smoking, asthma or emphysema cough accompanied by excessive phlegm (mucus) trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin. When using this product, do not exceed recommended dosage . Stop use and ask a doctor if redness or swelling is present new symptoms occur nervousness, dizziness or sleeplessness occurs fever gets worse or lasts more than 3 days pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) 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. 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Adverse Reactions
Not available.