FDA.reportPublic FDA data

Severe Cold and Flu Relief

Manufacturer
The Kroger Co.
Effective date
2024-06-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:00:26

Label at a glance#

ProductSevere Cold and Flu Relief Daytime
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN
Label structure9 sections

Indications and uses

temporarily relieves these symptoms due to a cold minor aches and pains nasal and sinus congestion minor sore throat headache cough due to minor throat and bronchial irritation temporarily reduces fever help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive

Dosage and administration

do not use more than directed do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. mL= milliliter keep dosing cup with product dose as follows or as directed by a doctor adults and children 12 years and over : 30 mL every 4 hours while symptoms last chlldren under 12 years of age: do not use 

Label contents#

Full prescribing information#

Active ingredients (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to a cold
    • minor aches and pains
    • nasal and sinus congestion
    • minor sore throat
    • headache
    • cough due to minor throat and bronchial irritation
  • temporarily reduces fever
  • help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive

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 inclide:

  • 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. 
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are allergic to acetaminophen
  • in a child under 12 years of age

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • 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

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 use more than directed.

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 a 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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 use more than directed
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • mL= milliliter
  • keep dosing cup with product
  • dose as follows or as directed by a doctor
  • adults and children 12 years and over : 30 mL every 4 hours while symptoms last
  • chlldren under 12 years of age: do not use 

Other information

OTHER SAFETY INFORMATION

  • each 30 mL contains: potassium 20 mg, sodium 18 mg 
  • store between 20-25ºC (68-77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO the  active ingredients of THERAFLU® EXPRESSMAX® SEVERE COLD & FLU *See back panel

Flu Relief Maximum Strength

DAYTIME • SEVERE COLD & FLU 

Acetaminophen 650 mg, Pain Reliever/Fever Reducer

Dextromethorphan HBr 20 mg, Cough Suppressant/

Guaifenesin 400 mg Expectorant/

Phenylephrine HCI 10 mg Nasal decongestant

Relieves

  • Body ache
  • Fever
  • Chest congestion
  • Nasal congestion
  • Headache
  • Cough
  • Sore throat pain

For ages 12 years and over

Alcohol Free

FL OZ (mL)

Berry Flavor

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER  CAP IS BROKEN OR MISSING.

*THERAFLU® IS A REGISTERED TRADEMARK OF GSK CONSUMER HEALTHCARE, PHILADELPHIA, PA 19112. GSK CONSUMER HEALTHCARE IS NOT AFFILIATED WITH THE KROGER CO. OR THIS PRODUCT

DISTRIBUTED BY THE KROGER CO.

CINCINNATI,OHIO 45202

www.kroger.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KROGER Maximum Strength Severe Flu Relief
KROGER Maximum Strength Severe Flu Relief

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
30142-71630142-716-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
GUAIFENESIN495W7451VQACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
MALTITOLD65DG142WKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT

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
6327d3d3-7ac7-4656-9adf-6fa562069db3cecd4f7f-5417-4e98-bc24-96803b6dfbe52024-06-20WarningsExact identifier
spl id: 6327d3d3-7ac7-4656-9adf-6fa562069db3
spl set id: cecd4f7f-5417-4e98-bc24-96803b6dfbe5

Reported adverse events (FAERS/openFDA)#

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