Otc - Active Ingredient
Active ingredients (In each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Daytime Cold And Flu Multi Symptom Capsule, Liquid Filled
FDA Label NDC 11673-975
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 Daytime Cold And Flu Multi Symptom (NDC 11673-975). 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, otc - keep out of reach of children, warnings, 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 Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
Otc - Purpose
Pain reliever/fever reducer, cough suppressant, Nasal Decongestant
Indications & Usage
temporarily relieves common cold/flu symptoms:
- nasal congestion
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
Dosage & Administration
| Directions |
|
| adults and children 12 yrs & over | 2 softgels with water every 4 hrs |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
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. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.
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 drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- Skin reddening
- Blisters
- Rash
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.
Package Label.Principal Display Panel
693t-target-daytime-coldnflu-24s (693t Target Daytime Coldnflu 24s)
* Please review the disclaimer below.
