FDA.reportPublic FDA data

Daytime Cold and Flu Relief

Manufacturer
TopCo Associates, LLC
Effective date
2023-10-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:58:49

Label at a glance#

ProductDaytime Cold and Flu Relief
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

Take only as directed  Do not exceed 4 doses in 24 hours    adults and children 12 years & over:  2 softgels with water every 4 hours children 4 to under 12 years:  ask a doctor children under 4 years:  do not use

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Use(s)

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
• more than 4 doses in 24 hrs, which is the maximum daily amount for this product
• 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,
occurs with or is followed by fever, headache, rash, nausea, or vomiting,
consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

  • 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 drugs. 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

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if

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

• you get nervous, dizzy or sleepless
• symptoms get worse or last more than 5 days (children) or 7 days (adults)
• 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 breastfeeding,

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

Taking more than directed can cause serious health problems. 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

  • Take only as directed
  •  Do not exceed 4 doses in 24 hours   

adults and children 12 years & over: 2 softgels with water every 4 hours

children 4 to under 12 years: ask a doctor

children under 4 years: do not use

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature 20-25 °C (68-77° F)
  • do not use if blister unit is torn or open

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40, FD&C yellow #6,
gelatin, glycerin, polyethylene glycol, povidone, propylene
glycol, purified water, sorbitol sorbitan solution, white edible ink

Questions/Comments

OTC - QUESTIONS SECTION

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Daytime Cold and Flu
Daytime Cold and Flu

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN3
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD3
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-065-16Daytime Cold and Flu Relief1 in 1 CARTONCAPSULE, LIQUID FILLED13
76162-065-16Daytime Cold and Flu Relief16 in 1 BLISTER PACKCAPSULE, LIQUID FILLED163

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-065DAYTIME COLD AND FLU RELIEF CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES, LLC]3Current NDC, 2 package rows20231104_d592fbb8-d4bf-444e-982e-edf6fe97dce4.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76162-06576162-065-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL SOLUTION8KW3E207O2IACT

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
Daytime Cold and Flu ReliefDAYTIME COLD AND FLU RELIEFTopCo Associates, LLCd592fbb8-d4bf-444e-982e-edf6fe97dce42023-10-31WarningsExact identifier
ndc (package): 76162-065-16
ndc (product): 76162-065
ndc11 (package): 76162006516
spl id: 97e61aee-34b7-468d-b3ea-6d796d4365da
spl set id: d592fbb8-d4bf-444e-982e-edf6fe97dce4

Reported adverse events (FAERS/openFDA)#

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