Otc - Active Ingredient
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Daytime Severe Cold And Flu Capsule, Liquid Filled
FDA Label NDC 41226-625
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Daytime Severe Cold And Flu (NDC 41226-625). 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, inactive ingredient, otc - purpose, indications & usage, dosage & administration, warnings, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
FD&C BLUE #1, FD&C RED #40, GELATIN, GLYCERIN, POLYETHYLENE GLYCOL, POVIDONE, PROPYLENE GLYCOL, PURFIED WATER, SHELLAC, CORBITOL SORBITAN SOLUTION, TITANTIUM DIOXIDE
Otc - Purpose
- Pain reliever/fever reducer
- Cough suppressant
- Expectorant
- Nasal decongestant
Indications & Usage
Uses
- temporarily relieves common cold/flu symptoms: nasal congestion - sinus congestion & pressure - cough due to minor throat & bronchial irritation - minor aches & pains - headache - fever - sore throat - reduces swelling of the nasal passages
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Dosage & Administration
Directions
- take only as directed -
- do not exceed 8 Softgels per 24 hrs -
- adults & children 12 yrs & over 2 Softgels with water every 4 hrs
- children 4 to under 12 yrs ask a doctor
- children under 4 yrs of age do not use
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
more than 8 LiquiCaps in 24 hours, which is the maximum daily amount for this product
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.
Otc - Keep Out Of Reach Of Children
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.
* Please review the disclaimer below.
