MedPath

Daytime Cold and Flu

Kroger Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylehrine HCl 5 mg Tablets

Approved
Approval ID

30d4a6c6-895e-3741-e063-6294a90ab192

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 23, 2025

Manufacturers
FDA

KROGER COMPANY

DUNS: 006999528

Products 1

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

Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code41226-675
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Product Specifications
Route of AdministrationORAL
Effective DateMay 23, 2025
FDA Product Classification

INGREDIENTS (15)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 10 mg in 1 1
Code: 9D2RTI9KYH
Classification: ACTIB
GUAIFENESINActive
Quantity: 200 mg in 1 1
Code: 495W7451VQ
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 04JA59TNSJ
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/23/2025

675R Kroger Daytime Cold and Flu

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/23/2025

Uses

  • for the temporary relief of the following cold/flu symptoms:

- minor aches and pains
- headache
- sore throat
- nasal congestion
- cough

  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/23/2025

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/23/2025

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/23/2025

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

WARNINGS SECTION

LOINC: 34071-1Updated: 5/23/2025

Warnings

**Liver warning:**This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/23/2025

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

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/23/2025

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
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 5/23/2025

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/23/2025

When using this product do not exceed recommended dose

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/23/2025

Stop use and ask a doctor if

  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 5/23/2025

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/23/2025

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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: 5/23/2025

Directions

*do not take more than directed. (see overdose warning)

adults and children 12 years and over

  • take 2 caplets every 4 hours
  • swallow whole; do not crush, chew or dissolve
  • do not take more than 10 caplets in 24 hours

children under 12 years

ask a doctor

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 5/23/2025

Other information

  • each caplet contains:sodium 3 mg
  • store at room temperature, between 20º - 25ºC (68º - 77ºF), and avoid excessive heat and humidity

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/23/2025

Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, crospovidone, D&C yellow no. 10 al. lake, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, talc, titanium dioxide, triacetin

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/23/2025

Questions or comments? Call1-800-632-6900

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Daytime Cold and Flu - FDA Drug Approval Details