Day Time Multi-symptom Cold And Flu Relief
FDA Label NDC 53943-604

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 Multi-symptom Cold And Flu Relief (NDC 53943-604). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Drug Facts


Active ingredients (in each Softgel)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCI 5 mg

Otc - Purpose

Purpose
Acetaminophen                    Pain reliever/Fever reducer
Dextromethorphan HBr        Cough suppressant
Phenylephrine HCI               Nasal Decongestant

Indications & Usage

Uses
temporarily relieves common cold and flu symptoms:
• nasal congestion
• cough due to minor throat and bronchial irritation
• sore throat
• headache
• minor aches and pain
• fever

Warnings

Warnings
Liver warning: This product contains
acetaminophen. Severe liver damage may occur if you take:
• more than 8 Liquid Caps in 24 hours • 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, occurs with or is followed by fever, headache, rash,
nausea or vomiting, consult a doctor promptly.


Otc - 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.

Otc - Ask Doctor

Ask a doctor before use if you have • liver disease • heart
disease • thyroid disease • diabetes • high blood pressure
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such 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.

Otc - Stop Use

Stop use and ask a doctor if
• you get nervous, dizzy or sleepless
• symptoms get worse or last 1) 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.

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.
In case of accidental overdose, get medical help or contact a
Poison Control Center right away. Quick medical attention is
critical for adults as well as for children, even if you do not notice
any signs or symptoms.

Dosage & Administration

Directions
• take only as directed (see Warning)
• do not exceed 4 doses per 24 hours

 adults and Children 12 yrs & over 2 softgels with water every 4 hours
 children 4 to under 12 yrs ask a doctor
 children under 4 years do not use

when using olher Daytime or Nighttime producls,
   carefully read each label to ensure correcl dosing

Other Safety Information

Other information

• store at room temperature 20-2S·C (68-77"F)
• avoid excessive heat

Inactive Ingredient

Inactive ingredientsFD&C Red #40, FD&C Yellow #06,

gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol,

Purified water, Sorbitol sorbitan solution, Titanium dioxide.

Otc - Questions

Questions? Call Weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Package Labeling: Discount Drug Mart Day Time Multi-Symptom Cold & Flu Relief

DISCOUNT                                                                  NDC-53943-604-03

drug mart

FOOD MARKET

Cold &
Flu Relief

MULTI-SYMPTOM

DAY TIME

*Compare to the active ingredients in Vicks® DayQuil™ Cold & Flu LiquiCaps™

24 Softgels

DISTRIBUTED BY:

DRUG MART - FOOD FAIR

211 COMMERCE DRIVE

MEDINA, OH 44256

www.discount-drugmart.com

This product is not manufactured or distributed by Procter
& Gamble, owner of the registered trademark Vicks®
DayOuilTM LiquiCapsTM

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO STORE

WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON

FOR DISSATISFACTION , NAME, ADDRESS AND EMPTY PACKAGE TO:

DISCOUNT DRUG MART, 211 COMMERCE DRIVE MEDINA, OHIO 44256

* Please review the disclaimer below.