Otc - Active Ingredient
Active ingredients( in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
Cold And Flu Nighttime Severe Capsule, Liquid Filled
FDA Label NDC 11673-983
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 Nighttime Severe (NDC 11673-983). 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 No. 1, gelatin, glycerin, shellac, titanium dioxide, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution
Otc - Purpose
Purpose
Pain reliever/Fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Indications & Usage
temporarily relieves common cold/flu symptoms:
- nasal congestion
- sinus congestion & pressure
- cough due to minor throat & bronchial irritation
- cough to help you sleep
- minor aches & pains
- headache
- fever
- sore throat
- runny nose & sneezing
- reduces swelling of nasal passages
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
Dosage & Administration
Directions
take only as directed - do not exceed 8 softgelsper 24 hrs - adults & children 12 yrs & over 2 Softgels with water every 4 hrs - children 4 to under 12 yrs ask a doctor - children ...
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 do not use
Warnings
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 ...
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
more than 8 Softgels 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
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 (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.
Package Label.Principal Display Panel
24 Count (626t)
* Please review the disclaimer below.
