Tukol A

Manufacturer
Genomma Lab USA, Inc. | AptaPharma Inc.
Effective date
2017-12-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:53:54

Label at a glance#

ProductTukol A
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure15 sections

Indications and uses

help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves these symptoms occurring with a cold - nasal congestion - cough due to minor throat and bronchial irritation

Dosage and administration

age                                               dose children 6 to 12 years                    2 tsp (10 mL) every 4 hours children 4 to 6 years                     1 tsp (5 mL) every 4 hours children under 4 years                  do not use do not exceed 6 doses in a 24-hour period use enclosed dosage cup tsp = teaspoon, mL = milliliter

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

DRUG FACTS


Active ingredients
(in each 5 mL, 1 teaspoon)
Dextromethorphan HBr, USP 5 mg
Guaifenesin, USP 50 mg
Phenylephrine HCL, USP 2.5 mg

Purpose

OTC - PURPOSE SECTION

Cough Suppressant
Expectorant
Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

  • help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporarily relieves these symptoms occurring with a cold - nasal congestion - cough due to minor throat and bronchial irritation

Warnings

WARNINGS SECTION

Do not use in a child

who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • cough that lasts or is chronic such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if the child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any other oral nasal decongestant or stimulant.

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

  • nervousness, dizziness, or sleeplessness occurs
  • symptoms do not get better within 7 days or are accompanied by a fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache These could be signs of a serious condition.

Keep out of reach of children

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 (1-800-222-1222) immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

age                                               dose

children 6 to 12 years                    2 tsp (10 mL) every 4 hours

children 4 to 6 years                     1 tsp (5 mL) every 4 hours

children under 4 years                  do not use

  • do not exceed 6 doses in a 24-hour period
  • use enclosed dosage cup
  • tsp = teaspoon, mL = milliliter

Other information

OTHER SAFETY INFORMATION

  • each 5 mL contains: sodium 3 mg
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD and C Blue # 1, FD and C Red # 40, flavor, glycerin, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1 877 99 GENOM (43666)

Children's Tukol Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children’s Tukol®

Cough Suppressant/Expectorant/Nasal Decongestant
Dextromethorphan HBr | Guaifenesin | Phenylephrine HCI

Ages 4+

Cough and Cold

Gets rid of phlegm
Quiets Cough
Clears nasal congestion

Grape Flavor

4 FL OZ (118 ml)

Drug Facts

Active ingredients                                            Purpose
(in each 5 mL, 1 teaspoon)
Dextromethorphan HBr, 5 mg ...............Cough suppressant
Guaifenesin, 50 mg. .......................................Expectorant
Phenylephrine HCI, 2.5 mg ................... Nasal decongestant

Uses
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
• temporarily relieves these symptoms occurring with a cold:
  • nasal congestion
  • cough due to minor throat and bronchial irritation

Warnings

Do not use in a child who is 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 the child has
• heart disease
• diabetes
• high blood pressure
• thyroid disease
• cough that lasts or is chronic such as occurs with asthma
• cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if the child is taking any other oral nasal decongestant or stimulant.

When using this product
• do not use more than directed

Stop use and ask a doctor if
• nervousness, dizziness, or sleeplessness occurs
• symptoms do not get better within 7 days or are accompanied by fever
• cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

Drug Facts (continued)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions
• do not exceed 6 doses in a 24-hour period
• use enclosed dosage cup
• tsp = teaspoon, mL = milliliter

        age                                       dose
children 6 to 12 years             2 teaspoons (10 mL) every 4 hours
children 4 to 6 years               1 teaspoons (5 mL) every 4 hours
children under 4 years             do not use

Other information
• each 5 mL contains: sodium 3 mg
• store at room temperature

Inactive ingredients citric acid, FD&C Blue # 1, FD&C Red # 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions or comments? 1-877-99 GENOM (43666)

Distributed by Genomma Lab USA., Houston, TX, 77027

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

LR-063 Rev. 2

PEEL HERE

Tukol-BTL-037-RV2Tukol-BTL-037-RV2

Children's Tukol Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children’s Tukol®


Cough Suppressant/Expectorant/Nasal Decongestant
Dextromethorphan HBr | Guaifenesin | Phenylephrine HCI

DO NOT USE IF PRINTED SEAL UNDER CAP
             IS TORN OR MISSING

Children’s Tukol®
Cough Suppressant/Expectorant/Nasal Decongestant
Dextromethorphan HBr | Guaifenesin | Phenylephrine HCI


Ages 4+

Cough and Cold

Gets rid of phlegm
Quiets Cough
Clears nasal congestion

Grape Flavor

4 FL OZ (118 ml)

LOT No.
Exp.

Drug Facts

Active ingredients                                               Purpose
(in each 5 mL, 1 teaspoon)
Dextromethorphan HBr, 5 mg ...............Cough suppressant
Guaifenesin, 50 mg. .......................................Expectorant
Phenylephrine HCI, 2.5 mg ................... Nasal decongestant

Uses
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
• temporarily relieves these symptoms occurring with a cold:
  • nasal congestion
  • cough due to minor throat and bronchial irritation

Warnings

Do not use in a child who is 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 the child has
• heart disease
• diabetes
• high blood pressure
• thyroid disease
• cough that lasts or is chronic such as occurs with asthma
• cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if the child is taking any other oral nasal decongestant or stimulant.

When using this product
• do not use more than directed

Stop use and ask a doctor if
• nervousness, dizziness, or sleeplessness occurs
• symptoms do not get better within 7 days or are accompanied by fever
• cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Distributed by
Genomma Lab USA Inc.,
Houston, TX 77027
Genomma Lab.®

     3
66975-3
    8/17

Drug Facts (continued)

Directions
• do not exceed 6 doses in a 24-hour period
• use enclosed dosage cup
• tsp = teaspoon, mL = milliliter

     age                                        dose
children 6 to 12 years         2 teaspoons (10 mL) every 4 hours
children 4 to 6 years           1 teaspoons (5 mL) every 4 hours
children under 4 years         do not use

Other information
• each 5 mL contains: sodium 3 mg
• store at room temperature

Inactive ingredients citric acid, FD&C Blue # 1, FD&C Red # 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions or comments? 1-877-99 GENOM (43666)

BX-037 Rev. 02
2FTAP1MUEWW1B

Tukol-BX-037-RV2Tukol-BX-037-RV2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1370205dextromethorphan HBr 5 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN4
1370205dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD4
1370205dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSY4
1370205dextromethorphan hydrobromide 5 MG / guaifenesin 50 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SolutionSY4

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
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
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
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-536-24Tukol A118 mL in 1 BOTTLELIQUID1184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-536TUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.]4Current NDC, Legacy NDC, 1 package rows20180101_651f0d7c-c76b-434d-95fd-427609b40b46.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH1
GUAIFENESINACTIVE INGREDIENT495W7451VQ1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS1
GUAIFENESINACTIVE MOIETY495W7451VQ1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SORBITOLINACTIVE INGREDIENT506T60A25R1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

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
50066-53650066-536-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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 4 · 206 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, DELAYED RELEASE / ORAL0.34 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOADROPS / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii+route
38 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL2350 mgExact identifier — unii+route
38 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE / ORALNAExact identifier — unii+route
38 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SUSPENSION / ORAL600 mgExact identifier — unii+route
38 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION, EXTENDED RELEASE / ORAL186.8 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, CHEWABLE / ORAL40 mgExact identifier — unii+route
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, EXTENDED RELEASE / ORAL2.22 mgExact identifier — unii+route
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii+route
38 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii+route
36 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE, FOR SUSPENSION / ORAL23 mgExact identifier — unii+route
36 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCAPSULE / ORAL131 mgExact identifier — unii+route
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii+route
38 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4FILM / ORAL1 mgExact identifier — unii+route
36 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii+route
38 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii+route
36 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE / ORAL5.4 mgExact identifier — unii+route
36 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETROCHE / ORAL948 mgExact identifier — unii+route
38 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii+route
36 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL36 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE PELLETS / ORAL0.02 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EXTENDED RELEASE / ORAL312 mgExact identifier — unii+route
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCAPSULE / ORAL8.5 mgExact identifier — unii+route
38 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION / ORAL100 mg/5mlExact identifier — unii+route
44 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, FILM COATED / ORAL2.5 mgExact identifier — unii+route
44 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION/ DROPS / ORAL22 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii+route
38 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET / ORAL56 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION/ DROPS / ORAL1 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
44 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii+route
36 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL48 mgExact identifier — unii+route
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPOWDER, FOR SOLUTION / ORAL98 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii+route
38 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, CHEWABLE / ORAL4 mgExact identifier — unii+route
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii+route
38 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING / ORAL0.15 mgExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route
38 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii+route
38 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SOLUTION / ORAL10 mg/5mlExact identifier — unii+route
38 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, LIQUID FILLED / ORAL1 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SOLUTION / ORAL123 mgExact identifier — unii+route
44 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED PELLETS / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLLIQUID / INTRAVENOUS18 mgExact identifier — unii+dosage form
44 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOZENGE / ORAL1264 mgExact identifier — unii+route
38 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSYRUP / ORAL268 mgExact identifier — unii+route
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION/ DROPS / ORAL15 mgExact identifier — unii+route
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii+route
38 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLFILM, SOLUBLE / ORAL7 mgExact identifier — unii+route
44 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4LOZENGE / ORAL115 mgExact identifier — unii+route
36 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
Tukol ADEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.651f0d7c-c76b-434d-95fd-427609b40b462017-12-28WarningsExact identifier
ndc (package): 50066-536-24
ndc (product): 50066-536
ndc11 (package): 50066053624
spl id: 158e568c-c1da-4e77-a6a4-34062f86f1fc
spl set id: 651f0d7c-c76b-434d-95fd-427609b40b46

Reported adverse events (FAERS/openFDA)#

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