FDA.reportPublic FDA data

Daytime COLD AND FLU Capsules

Manufacturer
PuraCap Pharmaceutical LLC | Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd
Effective date
2025-03-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:59

Label at a glance#

ProductDaytime COLD AND FLU
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache cough sore throat temporarily reduces fever

Dosage and administration

do not take more than the recommended dose adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 8 softgels in 24 hours or as directed by a doctor children under 12 years: do not use

Storage and handling

Store at room temperature. Aviod excessive heat.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each Softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to a cold or flu:
  • minor aches and pains
  • headache
  • cough
  • sore throat
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 10 softgels in 24 hours, 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

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.

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.

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 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
  • in children under 12 years of age

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough with excessive phlegm (mucus)
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain, 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.
  • nervousness, dizziness, or sleeplessness occurs

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center 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

  • do not take more than the recommended dose
  • adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 8 softgels in 24 hours or as directed by a doctor
  • children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature. Aviod excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Daytime Cold and Flu 8 SOFTGELS

NDC 51013-666-01

*Compare to the active ingredients in Vicks ®DayQuil® Cold & Flu LiquiCaps®

carton labelcarton label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1867684acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral CapsulePSN1
1867684acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral CapsuleSCD1
1867684acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral CapsuleSY1
1867684APAP 325 MG / Dextromethorphan Hydrobromide 10 MG Oral CapsuleSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51013-666-01Daytime COLD AND FLU1 in 1 CARTONCAPSULE, LIQUID FILLED11
51013-666-01Daytime COLD AND FLU8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51013-666DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]1Current NDC, 2 package rows20250313_300c7c7b-ea0b-3650-e063-6294a90a65e8.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51013-66651013-666-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

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 FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC300c7c7b-ea0b-3650-e063-6294a90a65e82025-03-11WarningsExact identifier
ndc (package): 51013-666-01
ndc (product): 51013-666
ndc11 (package): 51013066601
spl id: 300c7b40-7df4-a3f2-e063-6394a90af47c
spl set id: 300c7c7b-ea0b-3650-e063-6294a90a65e8

Reported adverse events (FAERS/openFDA)#

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