FDA.reportPublic FDA data

Vicks

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-10-05
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
daily-update
Hydrated at
2026-10-07 01:03:11

Label at a glance#

ProductVicks DayQuil and Vicks NyQuil Severe Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, 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  only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use

Storage and handling

each 15 mL contains:  sodium 47 mg store at no greater than 25C° and do not refrigerate

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DayQuil Severe Cold & Flu

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 15 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 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:

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product
  • child takes more than 4 doses (15 mL each) in 24 hrs, which is the maximum daily amount for this product
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product
Allergy Alert:

SPL UNCLASSIFIED SECTION

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:

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
  • a sodium-restricted diet

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 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over30 mL every 4 hrs
children 6 to under 12 yrs15 mL every 4 hrs
children 4 to under 6 yrsask a doctor
children under 4 yrsdo not use

Other information

STORAGE AND HANDLING SECTION

  • each 15 mL contains: sodium 47 mg
  • store at no greater than 25C° and do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C Yellow No. 6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

Questions?

OTC - QUESTIONS SECTION

1-800-362-1863

SPL UNCLASSIFIED SECTION

NyQuil Severe Cold & Flu

Drug Facts

Active ingredients (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal 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
Allergy Alert:

SPL UNCLASSIFIED SECTION

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:

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
  • 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
  • a sodium-restricted diet

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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over30 mL every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL dose cup contains: sodium 92 mg
  • store at no greater than 25°C and do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

Questions?

OTC - QUESTIONS SECTION

1-800-362-1683

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT:Do not use if printed shrinkband on bottle is broken or missing.

SPL UNCLASSIFIED SECTION

Dist. by Proctor & Gamble, Cincinnati OH 45202

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAX STRENGTH

VICKS
DAY & NIGHT PACK


VICKS ®

DayQuil™
SEVERE

COLD & FLU

Acetaminophen,Guaifenesin, Phenylephrine HCl, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains
Chest Congestion, Thins & Loosens Mucus

Nasal Congestion, Sinus Pressure
Cough

Non-Drowsy

Alcohol Free

NyQuil™
SEVERE

COLD & FLU

Acetaminophen, Phenylephrine HCl, Doxylamine Succinate, Dextromethorphan HBr

Headache, Fever, Sore Throat, Minor Aches & Pains

Nasal Congestion, Sinus Pressure

Sneezing, Runny Nose
Cough

Nighttime Relief


2 BOTTLES - 1 DAYQUIL/1 NYQUIL 12 FL OZ (354 mL) EACH; TOTAL 24 FL OZ OZ (708 ml)

814814

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix21512072814.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-814-242024-01-30C16284748780-1ba0f9c33-5b20-a910-e053-dadaa90a0b85Vicks ® DayQuil™ Severe and Vicks ® NyQuil Severe Cold and Flu Convenience Pack
37000-814-242024-01-30C16284748780-1ba0f9c33-5b20-a910-e053-dadaa90a0b85Vicks ® DayQuil™ Severe and Vicks ® NyQuil Severe Cold and Flu Convenience Pack
37000-814-242024-01-30C16284748780-1ba0f9c33-5b20-a910-e053-dadaa90a0b85Vicks ® DayQuil™ Severe and Vicks ® NyQuil Severe Cold and Flu Convenience Pack
37000-814-242022-10-11C16284748780-1ba0f9c33-5b20-a910-e053-dadaa90a0b85Vicks ® DayQuil™ Severe and Vicks ® NyQuil Severe Cold and Flu Convenience Pack
37000-814-242022-10-11C16284748780-1ba0f9c33-5b20-a910-e053-dadaa90a0b85Vicks ® DayQuil™ Severe and Vicks ® NyQuil Severe Cold and Flu Convenience Pack
37000-814-242022-10-11C16284748780-1ba0f9c33-5b20-a910-e053-dadaa90a0b85Vicks ® DayQuil™ Severe and Vicks ® NyQuil Severe Cold and Flu Convenience Pack
37000-814-242022-07-29C16284748780-1ba0f9c33-5b20-a910-e053-dadaa90a0b85Vicks ® DayQuil™ Severe and Vicks ® NyQuil Severe Cold and Flu Convenience Pack
37000-814-242022-07-29C16284748780-1ba0f9c33-5b20-a910-e053-dadaa90a0b85Vicks ® DayQuil™ Severe and Vicks ® NyQuil Severe Cold and Flu Convenience Pack
37000-814-242022-07-29C16284748780-1ba0f9c33-5b20-a910-e053-dadaa90a0b85Vicks ® DayQuil™ Severe and Vicks ® NyQuil Severe Cold and Flu Convenience Pack
37000-814-242021-02-12C16284748780-1ba0f9c33-5b20-a910-e053-dadaa90a0b85Vicks ® DayQuil™ Severe and Vicks ® NyQuil Severe Cold and Flu Convenience Pack
37000-814-242021-02-12C16284748780-1ba0f9c33-5b20-a910-e053-dadaa90a0b85Vicks ® DayQuil™ Severe and Vicks ® NyQuil Severe Cold and Flu Convenience Pack
37000-814-242021-02-12C16284748780-1ba0f9c33-5b20-a910-e053-dadaa90a0b85Vicks ® DayQuil™ Severe and Vicks ® NyQuil Severe Cold and Flu Convenience Pack
37000-814-242021-01-29C16284748780-1ba0f9c33-5b20-a910-e053-dadaa90a0b85Vicks ® DayQuil™ Severe and Vicks ® NyQuil Severe Cold and Flu Convenience Pack
37000-814-242021-01-29C16284748780-1ba0f9c33-5b20-a910-e053-dadaa90a0b85Vicks ® DayQuil™ Severe and Vicks ® NyQuil Severe Cold and Flu Convenience Pack
37000-814-242021-01-29C16284748780-1ba0f9c33-5b20-a910-e053-dadaa90a0b85Vicks ® DayQuil™ Severe and Vicks ® NyQuil Severe Cold and Flu Convenience Pack

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37000-810-08ML - Milliliter37000-810ebe602d1-6f18-4a11-85b3-59472304682512013-09-04
37000-810-12ML - Milliliter37000-810ccf072a8-87cc-49ff-a1e5-826df54176f912014-07-02
37000-812-08ML - Milliliter37000-812785eaef9-6f52-4cfd-8389-327c469d883112013-09-04
37000-812-12ML - Milliliter37000-8128242da34-dd3f-4efc-8c97-e2e94ff8574c12014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D2
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYH2
Doxylamine SuccinateACTIVE INGREDIENTV9BI9B5YI22
GuaifenesinACTIVE INGREDIENT495W7451VQ2
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJ2
AcetaminophenACTIVE MOIETY362O9ITL9D2
DextromethorphanACTIVE MOIETY7355X3ROTS2
DOXYLAMINEACTIVE MOIETY95QB77JKPL2
GuaifenesinACTIVE MOIETY495W7451VQ2
phenylephrineACTIVE MOIETY1WS297W6MV2
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QP2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBD2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOA2
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A82
glycerinINACTIVE INGREDIENTPDC6A3C0OX2
propylene glycolINACTIVE INGREDIENT6DC9Q167V32
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TY2
sodium benzoateINACTIVE INGREDIENTOJ245FE5EU2
sodium chlorideINACTIVE INGREDIENT451W47IQ8X2
sodium citrateINACTIVE INGREDIENT1Q73Q2JULR2
sorbitolINACTIVE INGREDIENT506T60A25R2
sucraloseINACTIVE INGREDIENT96K6UQ3ZD42
waterINACTIVE INGREDIENT059QF0KO0R2
xanthan gumINACTIVE INGREDIENTTTV12P4NEE2

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-81437000-814-24
37000-81037000-810-12
37000-81237000-812-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
152026-06-22monthly-update2026-07-17 21:35:04
132025-06-25full-release2026-06-01 01:03:57

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 1 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / ORAL75.3 mg/15mlExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / ORAL75.3 mg/15mlExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / ORAL75.3 mg/15mlExact identifier — unii+route+dosage form
4 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / ORAL75.3 mg/15mlExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / ORAL1.13 mg/15mlExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / ORAL1.13 mg/15mlExact identifier — unii+route+dosage form
4 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / ORAL148 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / ORAL148 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / ORAL148 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sodium chlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / ORAL148 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / ORAL1.13 mg/15mlExact identifier — unii+route+dosage form
4 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / ORAL1.13 mg/15mlExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii+route+dosage form
4 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
54db6d9b-0fb3-0052-e063-6394a90aa48ea17d0de4-85d1-47b7-ba72-3672ea65b3972026-06-22WarningsExact identifier
spl set id: a17d0de4-85d1-47b7-ba72-3672ea65b397

Reported adverse events (FAERS/openFDA)#

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