MedPath

Daytime Cold and Flu Relief

Kroger DayTime Severe Cooling Cold and Flu Relief

Approved
Approval ID

494e69ef-dc9f-4e14-b856-5eaf0f541a03

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

The Kroger Co.

DUNS: 006999528

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ACETAMINOHPEN, DEXTROMETHORPHAN HBr, GUAIFENESIN PHENYLEPHRINE HCL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code30142-722
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
ACETAMINOHPEN, DEXTROMETHORPHAN HBr, GUAIFENESIN PHENYLEPHRINE HCL
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (17)

ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
ACETAMINOPHENActive
Quantity: 650 mg in 30 mL
Code: 362O9ITL9D
Classification: ACTIB
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 20 mg in 30 mL
Code: 9D2RTI9KYH
Classification: ACTIB
GUAIFENESINActive
Quantity: 400 mg in 30 mL
Code: 495W7451VQ
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 10 mg in 30 mL
Code: 04JA59TNSJ
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/12/2025

Product Label

![KROGER Daytime Severe Cooling Cold and Flu Relief ](/dailymed/image.cfm?name=flu-relief-therapy-severe-cold-flu-berry- flavor-1.jpg&id=892277)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/20/2020

Uses

  • temporarily relieves common cold/flu symptoms:
    • nasal congestion
    • sinus congestion & pressure
    • cough due to minor throat and bronchial irritation
    • minor aches and pains
    • headache
    • fever
    • sore throat
    • reduce swelling of nasal passages
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage
  • help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/20/2020

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 2/20/2020

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

WARNINGS SECTION

LOINC: 34071-1Updated: 8/12/2025

Warnings

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

  • more than 4 doses in 24 hrs which is maximum daily amount for this product
  • taken 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

  • 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 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
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

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 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,

ask a health professional before use.

Keep out of reach of children.

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/12/2025

Directions

  • take only as directed
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hours

Adults & children 12 yrs & over

30 mL every 4 hrs.

Children 4 to under 12 yrs

Ask a doctor

Children under 4 yrs.

Do not use

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 2/20/2020

Other information

*each 30 mL contains: sodium 81 mg

  • store at room temperature. Do not refrigerate

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 2/20/2020

Inactive ingredients

citric acid, D&C Yellow No. 10, disodium edetate, FD&C Blue No. 1, natural and artificial flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/12/2025

Questions or comments?

1-800-632-6900

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