Otc - Active Ingredient
Active ingredients(in each softgel)
Acetaminophen, Phenylephrine HCl,
Dextromethorphan HBr, Guaifenesin
Cold And Flu Daytime Severe Capsule, Liquid Filled
FDA Label NDC 11673-972
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Target Corp for the product Cold And Flu Daytime Severe (NDC 11673-972). 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
Inactive Ingredients
polyethylene glycol 400, propylene glycol,povidone, shellac, titanium dioxide, gelatin, glycerin, soritol sorbitan solution, FD&C Blue no. 01, FD&C Red No. 40, Prified water
Otc - Purpose
PURPOSE:
- Minor aches and Pains, fever
- Nasal Congestion & Sinus Pressure
- Cough
- Chest Congestion
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 ...
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 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 LiquiCaps per 24 hrs - adults & children 12 yrs & over 2 LiquiCaps with water every 4 hrs - children 4 to under 12 yrs ask a doctor ...
take only as directed
do not exceed 8 softgels per 24 hrs
adults & children 12 yrs & over 2 softgelswith water every 4 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use
Warnings
Warnings
Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take - more than 8 softgels in 24 hrs, which is the maximum daily amount for this product - with other ...
Liver warning
This product contains acetaminophen.
Severe liver damage may occur if you take
more than 8 softgels 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, 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.
Overdose warning
In case of overdose, get medical help or contact a Poison Control Center right away. (1800-222-1222 Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
Package Label.Principal Display Panel
24 Count (625t)
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