Daytime Cold And Flu Liquid
FDA Label NDC 37835-527

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bi-mart for the product Daytime Cold And Flu (NDC 37835-527). 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, purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active ingredients (in each 15 mL dose cup)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough Suppressant

Nasal Decongestant

Uses

temporarily relieves common cold and flu symptoms:

  • minor aches and pains
  • headache
  • sore throat
  • fever
  • nasal congestion
  • cough due to minor throat and bronchial irritation

Warnings

Liver warning:This product contains acetaminophen. Sever liver damage may occur if:

  • adults and children over 12 years of age take more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
  • children 6 to 12 years of age take more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product
  • take with other drug containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product
  • Allergy alert:Acetaminophen may cause sever skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • ras
    • If skin reaction occurs, stop use and seek medical help right away.

      Sore throat warning:If sore throat is sever, lasts 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 products 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 diseas), or for 2 weeks after stopping the MAOI drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
      • If you have ever had an allergic reaction to this product or any o its ingredients

Ask A Doctor Before Use If You Have

  • liver disease
  • heart disease
  • high blood pressure
  • diabete
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • cough accompanied by excessive phlegm (mucus)
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema.

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.

When Using This Product

  • do not use more than directed (see overdose warning)
  • avoid alcoholic drinks

Stop Use And Ask A Doctor If

  • you get nervous, dizzy or sleepless
  • pain, nasal congestion or cough get worse or last more than 5 days (children) or 7 days (adults)
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning:

Taking more than the recommended dose (overdose) may cause serious health problemas including liver damamge. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if ou do not notice any signs or symptoms.

Directions

  • take only as directed (see Overdose warning)
  • measure only with dose cup provided and keep dose cup with product 
  • mL=mililiter
  • do not exceed 4 doses per 24 hours
  • AgeDose
    adults & children 12 years and over30 mL every 4 hours
     children 6 to under 12 years15 mL every 4 hours
     children under 6 yearsdo not use 

Other Information

  • each 15 mL contains:sodium 5 mg
  • store at room temperature 15-30°C (59-86°C) and do not refrigerate

Inactive Ingredients

Citric acid, FD&C Yellow No 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments?

1-844-912-4012

Package Label.Principal Display Panel

Label (Daytime Cold Flu)

Label (Daytime Cold Flu)

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