Day-time Cold/flu Relief Liquid
FDA Label NDC 53943-506

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Discount Drug Mart for the product Day-time Cold/flu Relief (NDC 53943-506). 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 factsactive ingredients (in each 15 ml, 1 tablespoon), purpose, keep out of reach of children, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Factsactive Ingredients (In Each 15 Ml, 1 Tablespoon)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCL 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Keep Out Of Reach Of Children

Keep this and all drugs out of the reach of children.

Uses

temporaily relieves these common cold/flu symptoms:

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

Warnings

DO NOT USE IF IMPRINTED SHRINK BRAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult/child takes:

  • more than 4 doses in 24 hours, which is the maxium daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using this product
  • Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vmiting, consult a doctor promptly

Do Not Use

  • if you are now taking a prescription monamine 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.
  • with any other drug containing acetaminophen (prescription or nonprescription) If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist

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
  • persistant or chronic cough such as occur with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucuc)

Ask A Doctor Or Pharmacist Before Use If

the user is taking the blood thinner 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
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • pain or cough gets worse or lasts more than 5 days (children) 7 days (adults)
  • redness or swelling is present
  • 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.

Overdose Warning:

Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage.  In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • take only as recommended (see overdose warning)
  • use dosage cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours
  •  age dose
     adults and children 12 years and over 30 mL (2 TBSP) every 4 hours
     children 6 years to under 12 years 15 mL (1 TBSP) every 4 hours
     children 4 years to under 6 years ask a doctor
     children under 4 years do not use

    * When using Day Time and Night Time products, carefully read each label to ensure correct dosing.

Other Information

  • sodium content per tablespoon: 10 mg
  • store at room temperature

Inactive Ingredients

citric acid, FD and C Yellow # 6, flavor, glycerin, propylene glycol, prified water, saccharin sodium, sodium benzoate, sucrose

Questions?

Call weekdays 1-877-798-5944

Discount Drug Mart Food Fair Orange Day-Time Non-Drowsy Cold/Flu Relief Product Label

*COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® DAYQUIL®

DISCOUNT

drug mart

FOOD FAIR

Orange Day-Time

NON-DROWSY COLD/FLU RELIEF

Acetaminophen ...... Pain Reliever/Fever Reducer

Dextromethorphan HBR ....... Cough Suppressant

Phenylephrine HCL ....... Nasal Decongestant

12 FL OZ (354 mL)

* This product is not manufactured or distributed by Proctor and Gamble owner of the registered trademark Vicks® DayQuil®

LR-064

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO THE STORE, SEND REASON FOR DISSATISFACTION , NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE MEDINNA, OHIO 44256

* Please review the disclaimer below.