Vicks DayQuil and Vicks NyQuil

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2020-01-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:46:36

Label at a glance#

ProductVicks DayQuil and Vicks NyQuil Severe Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE
Label structure20 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 hrs adults & children 12 yrs & over 2 caplets with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use when using other DayQuil or NyQuil ® products, carefully read each label to ensure correct dosing

Storage and handling

each caplet contains: sodium 4 mg store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DayQuil SEVERE COLD & FLU

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each caplet)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal 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

SPL UNCLASSIFIED SECTION

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

Sore throat warning

SPL UNCLASSIFIED SECTION

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

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 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.

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.

Overdose warning

SPL UNCLASSIFIED 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

adults & children 12 yrs & over2 caplets with water every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use
  • when using other DayQuil or NyQuil ® products, carefully read each label to ensure correct dosing

Other information

STORAGE AND HANDLING SECTION

  • each caplet contains: sodium 4 mg
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, crospovidone, FD&C Yellow No. 6, maltodextrin, mica, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-251-3374

SPL UNCLASSIFIED SECTION

NyQuil SEVERE COLD & FLU

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each caplet)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Doxylamine succinate 6.25 mgAntihistamine
Phenylephrine HCl 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • runny nose & sneezing
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen.

Severe liver damage may occur if you take

  • more than 4 doses 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

SPL UNCLASSIFIED SECTION

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.
  • to make a child sleep

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

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.

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.

Overdose warning

SPL UNCLASSIFIED 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

adults & children 12 yrs & over2 caplets with water every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use
  • when using other DayQuil ® or NyQuil products, carefully read each label to ensure correct dosing

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

crospovidone, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6, magnesium stearate, mica, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-362-1683

SPL UNCLASSIFIED SECTION

DIST. BY PROCTER & GAMBLE, CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 24 Caplet Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAX
STRENGTH
VICKS ®

DayQuil ®
SEVERE

COLD & FLU

Acetaminophen, Phenylephrine HCl,
Dextromethorphan HBr, Guaifenesin

  • Headache, Fever, Sore Throat,
    Minor Aches & Pains
  • Nasal/Sinus Congestion
    & Sinus Pressure
  • Cough
  • Chest Congestion

Non-Drowsy

16 DAYQUIL SEVERE CAPLETS;

NyQuil ®
SEVERE

COLD & FLU

Acetaminophen, Phenylephrine HCl,
Doxylamine Succinate, Dextromethorphan HBr

  • Headache, Fever, Sore Throat,
    Minor Aches & Pains
  • Nasal/Sinus Congestion
    & Sinus Pressure
  • Sneezing, Runny Nose
  • Cough

Nighttime Relief

8 NYQUIL SEVERE CAPLETS; TOTAL 24 CAPLETS

PRINCIPAL DISPLAY PANEL - 24 Caplet Kit Carton
PRINCIPAL DISPLAY PANEL - 24 Caplet Kit Carton

PRINCIPAL DISPLAY PANEL - 48 Caplet Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAX
STRENGTH
VICKS ®

DayQuil ®
SEVERE

COLD & FLU

Acetaminophen, Phenylephrine HCl,
Dextromethorphan HBr, Guaifenesin

  • Headache, Fever, Sore Throat,
    Minor Aches & Pains
  • Nasal/Sinus Congestion
    & Sinus Pressure
  • Cough
  • Chest Congestion

Non-Drowsy

32 DAYQUIL SEVERE CAPLETS;

NyQuil ®
SEVERE

COLD & FLU

Acetaminophen, Phenylephrine HCl,
Doxylamine Succinate, Dextromethorphan HBr

  • Headache, Fever, Sore Throat,
    Minor Aches & Pains
  • Nasal/Sinus Congestion
    & Sinus Pressure
  • Sneezing, Runny Nose
  • Cough

Nighttime Relief

16 NYQUIL SEVERE CAPLETS; TOTAL 48 CAPLETS

PRINCIPAL DISPLAY PANEL - 48 Caplet Kit Carton
PRINCIPAL DISPLAY PANEL - 48 Caplet Kit Carton

PRINCIPAL DISPLAY PANEL - 72 Caplet Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAX
STRENGTH
VICKS ®

DayQuil ®
SEVERE

COLD & FLU

Acetaminophen, Phenylephrine HCl,
Dextromethorphan HBr, Guaifenesin

  • Headache, Fever, Sore Throat,
    Minor Aches & Pains
  • Nasal/Sinus Congestion
    & Sinus Pressure
  • Cough
  • Chest Congestion

Non-Drowsy

48 DAYQUIL SEVERE CAPLETS;

NyQuil ®
SEVERE

COLD & FLU

Acetaminophen, Phenylephrine HCl,
Doxylamine Succinate, Dextromethorphan HBr

  • Headache, Fever, Sore Throat,
    Minor Aches & Pains
  • Nasal/Sinus Congestion
    & Sinus Pressure
  • Sneezing, Runny Nose
  • Cough

Nighttime Relief

24 NYQUIL SEVERE CAPLETS; TOTAL 72 CAPLETS

PRINCIPAL DISPLAY PANEL - 72 Caplet Kit Carton
PRINCIPAL DISPLAY PANEL - 72 Caplet Kit Carton

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D1
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYH1
Doxylamine SuccinateACTIVE INGREDIENTV9BI9B5YI21
GuaifenesinACTIVE INGREDIENT495W7451VQ1
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJ1
AcetaminophenACTIVE MOIETY362O9ITL9D1
DextromethorphanACTIVE MOIETY7355X3ROTS1
DoxylamineACTIVE MOIETY95QB77JKPL1
GuaifenesinACTIVE MOIETY495W7451VQ1
phenylephrineACTIVE MOIETY1WS297W6MV1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61U1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH481
crospovidoneINACTIVE INGREDIENT68401960MK1
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3G1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A81
magnesium stearateINACTIVE INGREDIENT70097M6I301
maltodextrinINACTIVE INGREDIENT7CVR7L4A2D1
micaINACTIVE INGREDIENTV8A1AW08801
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1A1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8H1
polyvinyl alcoholINACTIVE INGREDIENT532B59J9901
povidonesINACTIVE INGREDIENTFZ989GH94E1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU41
stearic acidINACTIVE INGREDIENT4ELV7Z65AP1
talcINACTIVE INGREDIENT7SEV7J4R1U1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP1

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-41637000-416-48
37000-41737000-417-72
37000-41537000-415-24

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 108 matching rows.

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 9 · 481 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
polysorbate 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / SOFT TISSUE4 mgExact identifier — unii candidate
78 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4GRANULE / ORAL5000 mgExact identifier — unii candidate
49 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, LIQUID FILLED / ORAL106 mgExact identifier — unii candidate
49 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPGRANULE, FOR SUSPENSION / ORAL143 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
34 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HSOLUTION/ DROPS / AURICULAR (OTIC)13 mgExact identifier — unii candidate
78 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETROCHE / ORAL30 mgExact identifier — unii candidate
30 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HLIQUID / INTRAVENOUS720 mgExact identifier — unii candidate
78 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, LIQUID FILLED / ORAL1 mgExact identifier — unii candidate
34 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, CHEWABLE / ORAL84 mgExact identifier — unii candidate
78 equally ranked IID candidates
polyvinyl alcoholPOLYVINYL ALCOHOL532B59J990CREAM / VAGINAL0.5 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, FILM COATED, EXTENDED RELEASE / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii candidate
40 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / TOPICAL8 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
maltodextrinMALTODEXTRIN7CVR7L4A2DCAPSULE / ORAL200 mgExact identifier — unii candidate
15 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRASYNOVIAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4SYSTEM / TRANSDERMAL35 mgExact identifier — unii candidate
49 equally ranked IID candidates
D&C Yellow No. 10D&C YELLOW NO. 1035SW5USQ3GGEL / TOPICALNAExact identifier — unii candidate
31 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR5 mgExact identifier — unii candidate
78 equally ranked IID candidates
polyvinyl alcoholPOLYVINYL ALCOHOL532B59J990SOLUTION / TOPICAL1.4 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
maltodextrinMALTODEXTRIN7CVR7L4A2DTABLET, ORALLY DISINTEGRATING / ORAL12 mgExact identifier — unii candidate
15 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSOAP / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE / ORAL7 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8DROPS / ORAL0.2 mg/1mlExact identifier — unii candidate
34 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET / SUBLINGUAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4LOZENGE / ORAL120 mgExact identifier — unii candidate
49 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii candidate
49 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET / ORAL233 mgExact identifier — unii candidate
78 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRALESIONAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HPOWDER, FOR SUSPENSION / ORAL396 mgExact identifier — unii candidate
78 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE / ORAL26.3 mgExact identifier — unii candidate
37 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRAMUSCULAR4 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
polyvinyl alcoholPOLYVINYL ALCOHOL532B59J990TABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
17 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8POWDER, FOR SOLUTION / ORAL40 mgExact identifier — unii candidate
34 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii candidate
26 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE PELLETS / ORAL24 mgExact identifier — unii candidate
40 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SOLUTION / ORAL690 mgExact identifier — unii candidate
28 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii candidate
26 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED, EXTENDED RELEASE / ORAL615 mgExact identifier — unii candidate
28 equally ranked IID candidates
D&C Yellow No. 10D&C YELLOW NO. 1035SW5USQ3GGUM, CHEWING / BUCCAL24 mgExact identifier — unii candidate
31 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, EXTENDED RELEASE / ORAL4.59 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8LOTION / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL144 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
37 equally ranked IID candidates
D&C Yellow No. 10D&C YELLOW NO. 1035SW5USQ3GSYRUP / ORAL4 mgExact identifier — unii candidate
31 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8SPONGE / TOPICAL0.01 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION / ORAL200 mgExact identifier — unii candidate
49 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET / BUCCAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, FILM COATED / ORAL24 mgExact identifier — unii candidate
78 equally ranked IID candidates
maltodextrinMALTODEXTRIN7CVR7L4A2DSUSPENSION / ORAL6040 mgExact identifier — unii candidate
15 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
39 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SUSPENSION / ORAL4441 mgExact identifier — unii candidate
28 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPFILM / BUCCAL3 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / ORAL1.13 mg/15mlExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / SUBLINGUAL1 mgExact identifier — unii candidate
34 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE / ORAL29520 mgExact identifier — unii candidate
28 equally ranked IID candidates
polyvinyl alcoholPOLYVINYL ALCOHOL532B59J990SUSPENSION / OPHTHALMIC1.4 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
polyvinyl alcoholPOLYVINYL ALCOHOL532B59J990AEROSOL, FOAM / VAGINAL0.5 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
povidonesPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii candidate
30 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
f67a1e15-ae09-2759-e053-2a95a90a8a3e2307f52c-8ea3-43b4-9b9f-bd60ac939f242023-03-09WarningsExact identifier
spl set id: 2307f52c-8ea3-43b4-9b9f-bd60ac939f24

Reported adverse events (FAERS/openFDA)#

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