Daytime Cold And Flu Reliefdrug Facts
DRUG FACTS
Daytime- Nighttime Cold And Flu Kit
FDA Label NDC 11673-969
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- Nighttime Cold And Flu (NDC 11673-969). 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 daytime cold and flu reliefdrug facts, otc - active ingredient, inactive ingredient, otc - purpose, indications & usage, dosage & administration, otc - keep out of reach of children, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredients (in each softgels)
- Acetaminophen 325 mg
- Dextromethorphan HBr 10 mg
- Phenylephrine HCl 5 mg
- Acetaminophen 325 mg
- Dextromethorphan HBr 15 mg
- Doxylamine succinate 6.25 mg
Active ingredients (in each softgel)
Inactive Ingredient
Inactive ingredients
FD&C blue 1, FD&C Yellow No. 10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, shellac, purified water, sorbitol sorbitan solution, titanium dioxide
FD&C red #40, FD&C Yellow No.6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, shellac, purified water, sorbitol sorbitan solution, titanium dioxide
Otc - Purpose
PURPOSE
|
temporarily relieves common cold/flu symptoms: nasal congestion
|
Indications & Usage
Uses
temporarily relieves common cold/flu symptoms:
- nasal congestion
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
- runny nose & sneezing
Uses
temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation - sore throat - headache - minor aches & pains - fever - runny nose & sneezing
temporarily relieves common cold/flu symptoms:
Dosage & Administration
| DIRECTIONS |
|
| adults & children 12 yrs & over | 2 Softgels with water every 6 hrs |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
| DIRECTION |
|
| 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 | 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 (1-800-222-1222). Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.
Keep out of reach of children
In case of overdose, get medical help or cotact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults and children even if you do not notice any signs or symptoms.
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
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
- 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.
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 ...
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.
Nightime Drug Facts
DRUG FACTS
Package Label.Principal Display Panel
48 Ct (695t)
* Please review the disclaimer below.
