Indications and 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
Tukol ® Children's Cough & Congestion Syrup
- Manufacturer
- Genomma Lab USA
- Effective date
- 2024-10-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-06-01 00:24:19
Label at a glance#
ProductTukol Children Cough and Congestion
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
Do not take more than 6 doses in any 24 hour period measure only with dosing cup provided keep dosing cup with product TSP = teaspoon age dose children 6 to under 12 years 2 teaspoons (10 mL) every 4 hours children 4 to under 6 years 1 teaspoon (5 mL) every 4 hours children under 4 years do not use
Storage and handling
each teaspoon (5 mL) contains: sodium 3 mg store at 15-30°C (59-86°F). Do not refrigerate.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active Ingredient (in each 5 mL or 1 teaspoon) | Purpose |
| Dextromethorphan HBr, 5 mg | Cough Suppressant |
| Guaifenesin, 50 mg | Expectorant |
| Phenylephrine HCl, 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
OTC - DO NOT USE 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.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if the child has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if the child istaking any other oral nasal decongestant or stimulant.
SPL UNCLASSIFIED SECTION
Do not exceed recommended dosage.
OTC - STOP USE SECTION
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 lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs of a serious condition.
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
- Do not take more than 6 doses in any 24 hour period
- measure only with dosing cup provided
- keep dosing cup with product
- TSP = teaspoon
| age | dose |
|---|---|
| children 6 to under 12 years | 2 teaspoons (10 mL) every 4 hours |
| children 4 to under 6 years | 1 teaspoon (5 mL) every 4 hours |
| children under 4 years | do not use |
Other information
- each teaspoon (5 mL) contains:sodium 3 mg
- store at 15-30°C (59-86°F). Do not refrigerate.
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?
1-877-994-3666
SPL UNCLASSIFIED SECTION
Distributed by:
Genomma Lab USA Inc.,
Houston, TX 77098
PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton
Tukol ®
Children's
COUGH & CONGESTION
Dextromethorphan HBr / Guaifenesin / Phenylephrine HCl
Ages
4+
Relieves:
- COUGH
- NASAL CONGESTION
- CHEST CONGESTION
4 FL OZ (118 ml)
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1370205 | dextromethorphan HBr 5 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution | PSN | 6 |
| 1370205 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 6 |
| 1370205 | dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution | SY | 6 |
| 1370205 | dextromethorphan hydrobromide 5 MG / guaifenesin 50 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution | SY | 6 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50066-308-04 | 2024-01-11 | C162847 | 48780-1 | 0191ceaa-6eca-198a-e063-dbdaa90aec3e | Tukol ® Children's Cough & Congestion Syrup |
| 50066-308-04 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6eca-198a-e063-dbdaa90aec3e | Tukol ® Children's Cough & Congestion Syrup |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50066-308-04 | Tukol Children Cough and Congestion | 118 mL in 1 BOTTLE, PLASTIC | SYRUP | 118 | 6 | |
| 50066-308-04 | Tukol Children Cough and Congestion | 1 in 1 CARTON | SYRUP | 1 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50066-308 | TUKOL CHILDREN COUGH AND CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [GENOMMA LAB USA] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241013_235a6d2b-7302-410c-be35-4d5ff7bbdfce.zip |
Products#
Every source-derived product name is available through these pages.
- Tukol Children Cough and Congestion
- Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
- ANHYDROUS CITRIC ACID
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- GLYCERIN
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SORBITOL
- SUCRALOSE
- XANTHAN GUM
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50066-308 | 50066-308-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Tukol Children Cough and Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA | 235a6d2b-7302-410c-be35-4d5ff7bbdfce | 2024-10-11 | Warnings | 50066-308-04 50066-308 50066030804 2439cdd1-e22d-530e-e063-6394a90ab78e 235a6d2b-7302-410c-be35-4d5ff7bbdfce |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.