Dosage & Administration
take only as directed
only use the dose cup provided
do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over
30 mL every 6 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
Nighttime Cold And Flu Liquid Cherry
FDA Label NDC 83393-555
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratorios Sanfer, S.a. De C.v. for the product Nighttime Cold And Flu Liquid Cherry (NDC 83393-555). 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 dosage & administration, warnings, inactive ingredient, indications & usage, otc - keep out of reach of children, otc - purpose, otc - active ingredient, 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
Warnings
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
more than 4 doses 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 skin reaction occurs, stop use and seek medical help right away
Sore throat warning: If sore throat is severe, persist for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Inactive Ingredient
Inactive ingredients alcohol, citric acid, D&C Yellow No. 10, FD&C Blue No.1, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose
Indications & Usage
Directions
take only as directed
only use the dose cup provided
do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over
30 mL 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
If pregnant or breast-feeding, ask a health professional before use. 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 as well as for children even if you do not notice any signs or symptoms
Otc - Purpose
Uses
temporarily relieves common cold/flu symptoms:
cough due to minor throat & bronchial irritation
sore throat
headache
minor aches & pains
fever
runny nose and sneezing
Otc - Active Ingredient
Active Ingredients (in each 30 mL) Purpose
Acetaminophen 650 mg……………………………………………………………………………………………………………….……….. Pain reliever/fever reducer
Dextromethorphan HBr 30 mg…………………………………………………………………………………………………….….………….……. Cough suppressant
Doxylamine succinate 12.5 mg………………………………………………………………………………………………………………………….……. Antihistamine
* Please review the disclaimer below.
