Active Ingredient(S)
Acetaminophen 325mg
Dextromethorphan HBr 10mg
Phenylephrine HCl 5mg
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates, Llc for the product Daytime Cold And Flu Relief (NDC 76162-065). 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 active ingredient(s), purpose, use(s), warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325mg
Dextromethorphan HBr 10mg
Phenylephrine HCl 5mg
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
• more than 4 doses in 24 hrs, which is the maximum daily amount for this product
• with other drugs containing 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,
occurs with or is followed by fever, headache, rash, nausea, or vomiting,
consult a doctor promptly.
• liver disease • heart disease • thyroid disease • diabetes • high blood pressure
• trouble urinating due to an enlarged prostate gland • cough that occurs
with too much phlegm (mucus) • persistent or chronic cough as occurs
with smoking, asthma, or emphysema
taking the blood thinning drug warfarin.
do not use more than directed
• you get nervous, dizzy or sleepless
• symptoms get worse or last more than 5 days (children) or 7 days (adults)
• fever gets worse or lasts 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.
ask a health professional before use.
Taking more than directed can cause serious health problems. 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.
adults and children 12 years & over: 2 softgels with water every 4 hours
children 4 to under 12 years: ask a doctor
children under 4 years: do not use
FD&C red #40, FD&C yellow #6,
gelatin, glycerin, polyethylene glycol, povidone, propylene
glycol, purified water, sorbitol sorbitan solution, white edible ink
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