MedPath

Cold and Flu Daytime Relief

Convenience Valet 44-012

Approved
Approval ID

1a520b4f-6a4b-4e37-94c5-9387f2e4c34a

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 15, 2025

Manufacturers
FDA

L.N.K. International, Inc.

DUNS: 038154464

Products 1

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

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50844-251
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2025
FDA Product Classification

INGREDIENTS (15)

ACETAMINOPHENActive
Quantity: 325 mg in 15 mL
Code: 362O9ITL9D
Classification: ACTIB
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 10 mg in 15 mL
Code: 9D2RTI9KYH
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 5 mg in 15 mL
Code: 04JA59TNSJ
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/15/2025

Principal display panel

24/7**life**
by 7-ELEVEN**™**

Cold&Flu
** DayTime Relief**

For Ages 6 Years & Over

Acetaminophen/ Pain Reliever/Fever Reducer
Dextromethorphan HBr / Cough Suppressant
Phenylephrine HCl / Nasal Decongestant

**Relieves:**Minor Aches & Pains, Sore Throat,
Fever, Headache, Nasal Congestion, Cough

compare to Vicks®
DayQuil®Cold & Flu
active ingredients*

Menthol
Flavor

6 FL OZ
** (177 mL)**

TAMPER EVIDENT: DO NOT USE IF PRINTED
** NECK WRAP IS BROKEN OR MISSING**

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

50844 REV0323A01245

65154L-SE-02-25-1

DISTRIBUTED BY****
** 7-ELEVEN, INC.**
IRVING, TX 75063
WWW.7-ELEVEN.COM

Satisfaction Guaranteed
** 1-800-255-0711**

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

![Convenience Valet 44-012](/dailymed/image.cfm?name=convenience- valet-44-012-1.jpg&id=897693)

Convenience Valet 44-012

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/15/2025

Uses

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/15/2025

Questions or comments?

1-877-507-6516

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/15/2025

Active ingredients (in each 15 mL)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/15/2025

Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

WARNINGS SECTION

LOINC: 34071-1Updated: 9/15/2025

Warnings

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

  • adult takes more than 4,000 mg of acetaminophen in 24 hours

  • child takes more than 5 doses in 24 hours

  • taken with other drugs containing acetaminophen

  • adult has 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.

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

Ask a doctor before use if the user has

  • difficulty in urination due to enlargement of the prostate gland

  • cough that occurs with too much phlegm (mucus)

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

  • heart disease

  • diabetes

  • thyroid disease

  • liver disease

  • high blood pressure

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • 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.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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: 9/15/2025

Directions

*do not take more than directed

  • do not exceed 4 doses per 24 hours
  • mL = milliliter
  • only use the dose cup provided

adults and children 12 years and over

30 mL every 4 hours

children 6 to under 12 years

15 mL every 4 hours

children under 6 years

do not use

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/15/2025

Other information

*each 15 mL contains: sodium 13 mg

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • use by expiration date on package

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/15/2025

Inactive ingredients

anhydrous citric acid, FD&C yellow #6, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sodium saccharin, sorbitol, sucralose

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