FDA.reportPublic FDA data

Daytime Severe Cold and Flu capsule, liquid filled

Manufacturer
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Effective date
2024-11-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:39:27

Label at a glance#

ProductDaytime Severe Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation minor aches & pains headache fever sore throat reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersom...

Dosage and administration

take only as directed - see  Overdose warning do not exceed 4 doses per 24 hours adults & children 12 years of age and over 2 softgels with water every 4 hours children 4 to under 12 years of age ask a doctor children under 4 years of age do not use when using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

Storage and handling

store at room temperature and avoid excessive heat

Label contents#

Full prescribing information#

Active ingredients (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine Hydrochloride 5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/ fever reducer

Cough suppressant 

Expectorant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves common cold/flu symptoms:
    • nasal congestion
    • sinus congestion & pressure
    • cough due to minor throat & bronchial irritation
    • minor aches & pains
    • headache
    • fever
    • sore throat
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

WARNINGS SECTION

Liver warning

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

  • more than 4 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.

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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

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
  • 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.

PREGNANCY 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.

Overdose warning

OVERDOSAGE SECTION

Taking more than directed can cause serious health problems. 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

  • take only as directed - see  Overdose warning
  • do not exceed 4 doses per 24 hours

adults & children 12 years of age and over

2 softgels with water every 4 hours

children 4 to under 12 years of age

ask a doctor

children under 4 years of age

do not use

  • when using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature and avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei
430206, China

PRINCIPAL DISPLAY PANEL - Shipping Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DAYTIME SEVERE COLD AND FLU CAPSULES Quantity : 3000 Capsules
NDC. No : 53345-021-01 IMPORTANT: Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate. CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING" shipper labelshipper label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1656815acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral CapsulePSN4
1656815acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD4
1656815APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53345-021-01Daytime Severe Cold and Flu1 in 1 BOXCAPSULE, LIQUID FILLED14
53345-021-01Daytime Severe Cold and Flu3000 in 1 BAGCAPSULE, LIQUID FILLED30004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53345-021DAYTIME SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]4Current NDC, Legacy NDC, 2 package rows20241127_cbd3a905-1c41-4cb0-8df6-36784430d627.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH1
GUAIFENESINACTIVE INGREDIENT495W7451VQ1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ1
ACETAMINOPHENACTIVE MOIETY362O9ITL9D1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS1
GUAIFENESINACTIVE MOIETY495W7451VQ1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A81
GELATININACTIVE INGREDIENT2G86QN327L1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A1
POVIDONEINACTIVE INGREDIENTFZ989GH94E1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SORBITOLINACTIVE INGREDIENT506T60A25R1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53345-02153345-021-01

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
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 124 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POVIDONEPOVIDONEFZ989GH94ETABLET, FOR SUSPENSION / ORAL2 mgExact identifier — unii+route
42 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESUSPENSION / ORAL20 mg/5mlExact identifier — unii+route
42 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, ORALLY DISINTEGRATING / ORAL15.03 mgExact identifier — unii+route
42 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, DELAYED RELEASE / ORALNAExact identifier — unii+route
42 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii+route
36 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, DELAYED RELEASE / ORAL36 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, DELAYED RELEASE / ORAL1.7 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, COATED / ORAL16 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii+route
40 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, EXTENDED RELEASE / ORAL428 mgExact identifier — unii+route
36 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, DELAYED RELEASE / ORAL1.7 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii+route
40 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET / ORAL337.28 mgExact identifier — unii+route
36 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, DELAYED RELEASE / ORAL36 mgExact identifier — unii+route
40 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii+route
36 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii+route
36 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route
42 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, CHEWABLE / ORAL48 mgExact identifier — unii+route
42 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, LIQUID FILLED / ORAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii+route
42 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3DROPS / ORAL200 mg/1mlExact identifier — unii+route
40 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, EXTENDED RELEASE / ORAL101 mgExact identifier — unii+route
42 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, ORALLY DISINTEGRATING / ORAL15.03 mgExact identifier — unii+route
42 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii+route
36 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, EXTENDED RELEASE / ORAL56 mgExact identifier — unii+route
42 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3ELIXIR / ORAL9306 mgExact identifier — unii+route
40 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii+route
36 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii+route
40 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route
36 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, DELAYED RELEASE PELLETS / ORAL32 mgExact identifier — unii+route
42 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route
42 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, EXTENDED RELEASE / ORAL101 mgExact identifier — unii+route
42 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESOLUTION / ORAL3000 mgExact identifier — unii+route
42 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route
40 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route
36 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route
40 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, LIQUID FILLED / ORAL1042 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
40 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL350 mgExact identifier — unii+route
42 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii+route
36 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION, EXTENDED RELEASE / ORAL1000 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii+route
40 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FOR SUSPENSION / ORAL2 mgExact identifier — unii+route
42 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EDROPS / ORALNAExact identifier — unii+route
42 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, COATED / ORAL16 mgExact identifier — unii+route
40 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, COATED / ORAL12.96 mgExact identifier — unii+route
36 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, DELAYED RELEASE / ORALNAExact identifier — unii+route
42 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3DROPS / ORAL200 mg/1mlExact identifier — unii+route
40 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route
42 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, COATED / ORAL12.96 mgExact identifier — unii+route
36 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route
40 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii+route
36 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EPOWDER, FOR SUSPENSION / ORAL35 mg/5mlExact identifier — unii+route
42 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii+route
40 equally ranked IID candidates

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 Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.cbd3a905-1c41-4cb0-8df6-36784430d6272024-11-25WarningsExact identifier
ndc (package): 53345-021-01
ndc (product): 53345-021
ndc11 (package): 53345002101
spl id: 27c7750e-5d1b-f49a-e063-6394a90a06ae
spl set id: cbd3a905-1c41-4cb0-8df6-36784430d627

Reported adverse events (FAERS/openFDA)#

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