The following Structured Product Label (SPL) was submitted to the FDA by Time Cap Laboratories,inc for the product Maximum Strength Day Cold And Flu And Night Severe Cold And Flu (NDC 49483-726). 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, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in each caplet)
Day Cold & Flu
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Active ingredients (in each caplet)
Night Severe Cold & Flu
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Triprolidine HCl 1.25 mg
Purposes
Day Cold & Flu
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Purposes
Night Severe Cold & Flu
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Antihistamine
Uses
Day Cold & Flu
• temporarily relieves these common cold and flu symptoms:
o cough
o nasal congestion
o minor aches and pains
o sore throat
o headache
o stuffy nose
o sinus congestion and pressure
• temporarily reduces fever
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Night Severe Cold & Flu
• temporarily relieves these common cold and flu symptoms:
o cough
o nasal congestion
o minor aches and pains
o sore throat
o headache
o sneezing
o sinus congestion and pressure
o runny nose
o itching of the nose or throat
o itchy, watery eyes due to hay fever
• temporarily reduces fever
• controls cough to help you get to sleep
Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
• more than 4,000 mg 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.
Do not use
Ask a doctor before use if you have
• liver disease
• heart disease
• diabetes
• high blood pressure
• thyroid disease
• glaucoma
(Night Severe Cold & Flu only)
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis
(Night Severe Cold & Flu only)
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers
(Night Severe Cold & Flu only)
When using this product
• do not use more than directed
• excitability may occur, especially in children
(Night Severe Cold & Flu only)
• marked drowsiness may occur
(Night Severe Cold & Flu only)
• alcohol, sedatives, and tranquilizers may increase drowsiness
(Night Severe Cold & Flu only)
• avoid alcoholic drinks
(Night Severe Cold & Flu only)
• use caution when driving a motor vehicle or operating machinery
(Night Severe Cold & Flu only)
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
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.
Directions
Day Cold & Flu
•
do not take more than directed (see Overdose warning)
• do not take more than 12 caplets in any 24-hour period
• adults and children 12 years of age and over: take 2 caplets every 4 hours
• children under 12 years of age: do not use
Night Severe Cold & Flu
• do not take more than directed (see Overdose warning)
• do not take more than 8 caplets in any 24-hour period
• adults and children 12 years of age and over: take 2 caplets every 4 hours
• children under 12 years of age: do not use
Other information
Inactive ingredients Day Cold & Flu
colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
Inactive ingredients Night Severe Cold & Flu
colloidal silicon dioxide, croscarmellose sodium, mica, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid, talc, titanium dioxide, yellow iron oxide
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