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Acetaminophe, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl, Triprolidine Hcl Tablets

OTC RxCUI 1110988
Contents

Overview

Label date
2023-09-18

Indications and usage

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

Purpose

s 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

Dosage and administration

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

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

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 if

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

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

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

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.

Overdosage

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.

Pregnancy or breast-feeding

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

Active ingredient (label)

s (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

Inactive ingredients

s 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

Keep out of reach of children

of children.