Otc - Active Ingredient
- Acetaminophen
- PhenylephrineHCl,
- Doxylamine Succinate
- Dextromethorphan HBr
Nighttime Severe Cold And Flu Capsule, Liquid Filled
FDA Label NDC 41226-626
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 for the product Nighttime Severe Cold And Flu (NDC 41226-626). 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 BLUE #1, GELATN, GLYCERIN, POLYETHYLENE GLYCOL, POVIDONE, PROPYLENE GLYCOL, PURIFIED WATER, SHELLAC, SORBITOL SORBITAN SOLUTION, TITANIUM DIOXIDE
Otc - 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
take only as directed
do not exceed 8 Softgels per 24 hours
- 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
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.
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
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.
* Please review the disclaimer below.
