Non Drowsy Daytime Cold And Flu Softgel
FDA Label NDC 30142-768

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Non Drowsy Daytime Cold And Flu Softgel (NDC 30142-768). 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 other, otc - purpose, uses, liver warning, allergy alert, sore throat warning, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredients (in each Softgel)Purposes
Acetaminophen 325 mgPain reliever / Fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Phenylephrine HCl 5 mgNasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

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

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
  • 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, 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 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 You Have

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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Otc - When Using

When using this product, do not use more than directed.

Stop Use And Ask A Doctor If

  • you get nervous, dizzy or sleepless
  • pain, nasal congestion or cough get worse or last 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 rash or headache that lasts. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

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 directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

  • take only as directed - see Overdose warning
  • do not exceed 4 doses per 24 hrs
    • adults & children 12 yrs & over2 softgels with water every 4 hrs
    children 4 to under 12 yrsask a doctor
    children under 4 yrsdo not use

Other Information

  • store at room temperature between 20-25 °C (68-77 °F)

Inactive Ingredients

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments

1-800-632-6900

Principal Display Panel - 325 Mg Capsule Blister Pack Carton

NDC 30142-768-48
*Compare to active ingredients in
Vicks® Dayquil™ Cold & Flu Liquicaps™

NON-DROWSY
RELIEF

COLD & FLU
DayTime

Multi-Symptom Relief
Pain Reliever
Fever Reducer
Cough Suppressant
Nasal Decongestant

Acetaminophen 325mg
Dextromethorphan HBr 10mg
Phenylephrine HCl 5mg

48
SOFTGELS

Principal Display Panel (325 mg Capsule Blister Pack Carton)

Principal Display Panel (325 mg Capsule Blister Pack Carton)

* Please review the disclaimer below.