MedPath

Daytime Cold Flu

Drug Facts

Approved
Approval ID

85093d7e-55f4-46c6-b96f-146557a21e46

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 30, 2025

Manufacturers
FDA

Good Sense (Geiss, Destin & Dunn, Inc.)

DUNS: 076059836

Products 1

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

Acetaminophen Dextromethorphen HBr Phenylephrine HCL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50804-898
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen Dextromethorphen HBr Phenylephrine HCL
Product Specifications
Route of AdministrationORAL
Effective DateJuly 30, 2025
FDA Product Classification

INGREDIENTS (16)

PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 04JA59TNSJ
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 10 mg in 1 1
Code: 9D2RTI9KYH
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITANInactive
Code: 6O92ICV9RU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/30/2025

Package Label

Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg

GOODSENSE DayTime Cold and Flu Relief

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/30/2025

Uses

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/30/2025

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethoprhan HBr 10 mg

Phenlyephrine HCl 5 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/30/2025

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 7/30/2025

Other information

  • store between 15-30ºC (59-86ºF)
  • avoid excessive heat

WARNINGS SECTION

LOINC: 34071-1Updated: 7/30/2025

Warnings

**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

  • 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.

Ask a doctor before use if you have

  • liver disease
  • diabetes
  • heart disease
  • thyroid disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product,

do not exceed recommended dosage.

Stop use and ask a doctor if

  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • nervousness, dizziness, or sleeplessness occur
  • 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,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose can cause liver damage. 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.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 7/30/2025

Questions or comments?

Call** 1-877-753-3935**Monday-Friday 9AM-5PM EST

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/30/2025

Directions

*do not take more than directed (see Overdose warning)

  • do not take more than 4 doses in 24 hours
  • adults and children 12 years and over: take 2 softgels with water every 4 hours
  • swallow whole; do not crush, chew, or dissolve
  • children under 12 years: do not use *when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/30/2025

Inactive ingredients

FD&C red #40, FD&C yellow#6, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink

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Daytime Cold Flu - FDA Drug Approval Details