Active Ingredients (In Each Softgel)
Acetaminophen 325 mg
Dextromethoprhan HBr 10 mg
Guaifenesin 200 mg
Phenlyephrine HCl 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Daytime Severe Cold And Flu Relief (NDC 51316-101). 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 ingredients (in each softgel), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325 mg
Dextromethoprhan HBr 10 mg
Guaifenesin 200 mg
Phenlyephrine HCl 5 mg
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
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.
taking the blood thinning drug warfarin.
do not use more than
directed.
■ you get nervous,
dizzy or sleepless ■ pain, nasal congestion, 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 rash or headache
that lasts
These could be signs of a serious condition.
ask a health professional before use.
Overdose warning: Taking more than the recommended dose can 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.
■ take only as directed
■ do not exceed 8 softgels per 24 hours
| adults & 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 |
■ when using other Nighttime or Daytime products,
carefully read each label to ensure correct dosing
FD&C Yellow # 6, gelatin, glycerin, polyethylene glycol,
povidone, propylene glycol, purified water, sorbitol
sorbitan , titanium dioxide
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