FDA.reportPublic FDA data

Cold and Flu Relief

Manufacturer
Discount Drug Mart | LNK International, Inc.
Effective date
2021-05-07
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:45:14

Label at a glance#

ProductCold and Flu Relief Multi-Symptom, DayTime
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

do not take more than directed do not take more than 8 capsules per 24 hours adults and children 12 years and over: take 2 capsules with water every 4 hours children under 12 years: ask a doctor

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) protect from heat, humidity and light see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredients (in each liquid-filled capsule)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day 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

OTC - DO NOT USE SECTION

  • 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • 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

OTC - ASK DOCTOR SECTION

  • liver disease
  • thyroid disease
  • diabetes
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • heart disease
  • high blood pressure
  • cough that occurs with too much phlegm (mucus)
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • do not take more than 8 capsules per 24 hours
  • adults and children 12 years and over: take 2 capsules with water every 4 hours
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from heat, humidity and light
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DISCOUNT
drug
mart
FOOD FAIR

NDC 53943-659-09

MAY CONTAIN ANTI-THEFT DEVICE

Cold & Flu Relief
MULTI-SYMPTOM
DayTime

Acetaminophen, Dextromethorphan HBr,
Phenylephrine HCl

• Pain Reliever/Fever Reducer
• Cough Suppressant
• Nasal Decongestant

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

Actual Size

Non-Drowsy

20 Liquid Caps

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark Vicks® DayQuil® Cold & Flu LiquiCaps®.

Product of China. Packaged and Quality Assured in the USA

50844        ORG041865909

DISTRIBUTED BY:
DRUG MART - FOOD FAIR
211 COMMERCE DRIVE
MEDINA, OH 44256
www.discount-drugmart.com

SATISFACTION GUARANTEED
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

Drug Mart 44-659
Drug Mart 44-659

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53943-65953943-659-09

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d0530e7a-6016-42ea-a13c-3b4c9e16f260fe2e1729-e5b2-4f72-a991-f0f5ea24f0852021-05-07WarningsExact identifier
spl id: d0530e7a-6016-42ea-a13c-3b4c9e16f260
spl set id: fe2e1729-e5b2-4f72-a991-f0f5ea24f085

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.