Maximum strength Day cold and flu and Night severe cold and flu

Acetaminophe, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl, Triprolidine HCl Tablets · Kit

Over the counter

Active ingredient

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

Purpose

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

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

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

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before 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

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

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

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

Pregnancy or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children.

Directions

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

Inactive ingredients

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

Questions?

Questions or Comments? Call 1-877-290-4008

Label text from the FDA structured product label by TIME CAP LABORATORIES,INC (revised Sep 18, 2023). Long sections are shortened; the complete label is on DailyMed.

Maximum strength Day cold and flu and Night severe cold and flu NDC products (1)

NDCStrength & formLabelerType
49483-726
Kit
TIME CAP LABORATORIES,INCOTC MONOGRAPH DRUG

Frequently asked questions

What is Maximum strength Day cold and flu and Night severe cold and flu used for?

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 •…

Who makes Maximum strength Day cold and flu and Night severe cold and flu?

Maximum strength Day cold and flu and Night severe cold and flu is listed by 1 labeler in the FDA NDC directory, including TIME CAP LABORATORIES,INC.