Drug Facts Day Maximum Strength Cold And Flu Relief
DAY MAXIMUM STRENGTH COLD AND FLU RELIEF
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid for the product Day Maximum Strength Cold And Flu Relief (NDC 11822-8557). 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 drug facts day maximum strength cold and flu relief, 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.
DAY MAXIMUM STRENGTH COLD AND FLU RELIEF
Active ingredients (in each SOFTGEL)
Active ingredients in each softgel
Inactive ingredients: FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
FD&C blue#1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
Purpose
ACETAMINOPHEN/Pain Reliever-Fever Reducer
Dextromethorphan Hydrobromide/Cough Suppressant
Doxylamine Succinate/Antihistamine
Phenylephrine HCl/Nasal Decongestant
temporarily relieves these symptoms due to a cold or flu:
minor aches and pains · headache · cough
· sore throat · nasal and sinus congestion
temporarily reduces fever
temporarily relieves these symptoms due to a cold or flu:
temporarily reduces fever
Directions:· do not take more than the recommended dose
· adults and children 12 years and over: take 2 softgels with water
every 4 hours.
Do not exceed 10 softgels in 24 hours or as directed by a doctor.
· children under 12 years: do not use
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.
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 4,000 mg of acetaminophen in 24 hours
· with other drugs containing acetaminophen
· 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin or severe
allergic reactions. Symptoms may include:
· skin reddening · blisters · rash · hives
· facial swelling · asthma (wheezing) · shock
If a skin or general allergic 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 4,000 mg of acetaminophen in 24 hours
· with other drugs containing acetaminophen
· 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin or severe
allergic reactions. Symptoms may include:
· skin reddening · blisters · rash · hives
· facial swelling · asthma (wheezing) · shock
If a skin or general allergic 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.
NIGHT MAXIMUM STRENGTH COLD AND FLU RELIEF
Directions:· do not take more than the recommended dose
· adults and children 12 years and over: take 2 softgels water every 4 hours. Do not exceed 10 softgels in 24 hours or as
directed by a doctor.
· children under 12 years: do not use
* Please review the disclaimer below.