Otc - Active Ingredient
Acetaminophen 325 mg
Dextromethorphan Hydrobromide 10 mg
Phenylephrine Hydrochloride 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Daytime Cold And Flu (NDC 41226-693). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325 mg
Dextromethorphan Hydrobromide 10 mg
Phenylephrine Hydrochloride 5 mg
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Uses
Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
Allergy alert: Acetaminophen may cause severe skin reactions. symptoms may include:
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
Ask a doctor before use if you have
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
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
adults & children 12 years & over: 2 softgels with water every 4 hrs
children 4 to under 12 yrs: ask a doctor.
children under 4 yrs: do not use
Other information
Inactive ingredients FD&C red #40,FD&C yellow #6,gelatin,glycerin, polyethylene glycol, povidone,propylene glycol,purified water,shellac,sorbitol sorbitan solution,titanium dioxide.
Questions? 1-800-632-6900
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