The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar Services for the product Maximum Strength Cold And Flu (NDC 55319-628). 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.
ACTIVE INGREDIENTS
Active ingredients (in each softgel) acetamnophen 325 mg - Dextromethorphan HBr 10mg - Gualifenesin 200 mg - Phenylephrine HCl 5 mg
Active ingredients (in each softgel)
acetamnophen 325 mg
Dextromethorphan HBr 10mg
Gualifenesin 200 mg
Phenylephrine HCl 5 mg
INACTIVE INGREDIENTS
Inactive ingredients: FD&C yellow#6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
Inactive ingredients:
FD&C yellow#6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
PURPOSE
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
NDICATIONS & USAGE
temporarily relieves these common cold and flu symptoms: nasal congestion - headache - cough - minor aches and pains - sore throat - temporarily reduces fever - promotes nasal and/or sinus drainage - helps ...
temporarily relieves these common cold and flu symptoms:
nasal congestion
headache
cough
minor aches and pains
sore throat
temporarily reduces fever
promotes nasal and/or sinus drainage
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Directions
Do not take more than directed (see Overdose warning) do not take more than 12 SOFTGELS in any 24-hour period \
adults and children 12 years of age and over: take 2 SOFTGELS every 4 hours
children under 12 years of age: do not use
KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. Overdose warning - Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center ...
Keep out of reach of children.
Overdose warning
Taking more than the recommended dose (overdose) may cause liver damage. 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 12softgels in 24 hours, which is the maximum daily amount - with other drugs ...
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take:
more than 12 softgels in 24 hours, which is the maximum daily amount
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
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.
