Indications and uses
Temporarily relieves these common cold and flu symptoms minor aches and pain headache sore throat nasal congestion cough due to minor throat and bronchial irritation temporarily reduces fever
Tukol Honey Daytime and Nighttime Value Pack
- Manufacturer
- Genomma Lab USA
- Effective date
- 2024-10-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- full-release
- Hydrated at
- 2026-06-01 00:28:37
Label at a glance#
ProductTukol Honey Daytime and Nighttime Value Pack
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure18 sections
Dosage and administration
do not take more than directed do not take more than 4 doses in any 24 hours this adult strength product is not intended for use in children under 12 years of age measure only with dosing cup provided keep dosing cup with product mL = mililiter TBSP = tablespoon dose as follows Adults and children 12 years or age and over 30 mL (2 tablespoons) every 4 hours Children under 12 years Do not use When using Day Time an...
Storage and handling
Each 30 mL contains sodium: 18 mg store between 15-30 o C (59-86 o F) do not refrigerate
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Cold & Flu Day Time Multi-Symptom Relief with Natural Honey
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active Ingredients (in each 30 mL) | Purpose |
|---|---|
| Acetaminophen 650 mg | Pain reliever/Fever reducer |
| Dextromethorphan HBr 20 mg | Cough suppressant |
| Phenylephrine HCl 10 mg | Nasal Decongestant |
Uses
Temporarily relieves these common cold and flu symptoms
- minor aches and pain
- headache
- sore throat
- nasal congestion
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
Warnings
Liver warning
The product contains Acetaminophen. Severe liver damage may occur if you take
- more than 4 doses (30 mL each) 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
Acetaminophen may cause severe skin reactions. Symptoms may include
- skin reddening
- blisters
- rash.
If skin reaction occurs, stop use and seek medical help right away.
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
- 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 two 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
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
- cough accompanied by excessive phlegm (mucus)
Ask a doctor or pharmacist before use
- if you are taking the blood thinning drug warfarin
When using this product
- do not use more than directed (see overdose warning)
- avoid alcoholic drinks
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- fever gets worse or lasts more than 3 days
- pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- redness or swelling is present
- cough comes back, or occurs with rash or headache that lasts.
- new symptoms occur
- 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
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not noticve any signs or symptoms.
Directions
- do not take more than directed
- do not take more than 4 doses in any 24 hours
- this adult strength product is not intended for use in children under 12 years of age
- measure only with dosing cup provided
- keep dosing cup with product
- mL = mililiter
- TBSP = tablespoon
- dose as follows
| Adults and children 12 years or age and over | 30 mL (2 tablespoons) every 4 hours |
| Children under 12 years | Do not use |
| |
Other information
- Each 30 mL contains sodium: 18 mg
- store between 15-30 oC (59-86 oF)
- do not refrigerate
Inactive ingredients
Citric acid, FD&C Yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose
Questions or comments?
1-877-994-3666
Monday to Friday from 8 am to 6 pm, Central Time
SPL UNCLASSIFIED SECTION
Cold & Flu Night Time Multi-Symptom Relief with Natural Honey
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active Ingredients (in each 30 mL) | Purpose |
|---|---|
| Acetaminophen 650 mg | Pain reliever/Fever reducer |
| Dextromethorphan HBr 30 mg | Cough suppressant |
| Doxylamine Succinate 12.5 mg | Antihistamine |
Uses
Temporarily relieves these common cold and flu symptoms:
- sore throat
- headache
- minor aches and pain
- runny nose and sneezing
- cough due to minor throat and bronchial irritation
- temporarily reduces rever
Warnings
Liver warning
The product contains Acetaminophen. Severe liver damage may occur if you take
- more than 4 doses (30 mL each) 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
Acetaminophen may cause severe skin reactions. Symptoms may include
- skin reddening
- blisters
- rash.
If skin reaction occurs, stop use and seek medical help right away.
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
- with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
- for more than 10 days for pain unless directed by a doctor.
- for more than 3 days for fever unless directed by a doctor
- 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 sleepy
Ask a doctor before use if you have
- liver disease
- 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 an enlarged prostate gland.
Ask a doctor or pharmacist before use
- if you are taking sedatives or tranquillizers
- if you are taking the blood thinning drug warfarin
When using this product
- do not use more than directed
- avoid alcoholic drinks
- excitability may occur, especially in children,
- marked drowsiness may occur
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
Stop use and ask a doctor if
- redness or swelling is present
- symptoms do not get better within 7 days or are accompanied by a fever
- fever gets worse or lasts more than 3 days
- new symptoms occur
- cough lasts more than 7 days, comes back, or occurs with fever, 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
Taking more than the recommended dose may 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 noticve any signs or symptoms.
Directions
- do not take more than directed
- do not take more than 4 doses in any 24 hours
- this adult strength product is not intended for use in children under 12 year of age
- measure only with dosing cup provided
- keep dosing cup with product
- mL = mililiter
- TBSP = tablespoon
- dose as follows
| Adults and children 12 years of age and over | 30 mL (2 tablespoons) every 6 hours |
| Children under 12 years of age | Do not use |
when using day time and night time products, carefully read each label to ensure correct dosing
Other information
- Each 30 mL contains sodium 18 mg
- store between 15-30 oC (59-86 oF)
- do not refrigerate
Inactive ingredients
Citric acid, FD&C Yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose
Questions or comments?
1-877-994-3666 Monday to Friday from 8 am to 6 pm, Central Time.
SPL UNCLASSIFIED SECTION
Distributed by:
Genomma Lab USA Inc.,
Houston, TX 77098
PRINCIPAL DISPLAY PANEL - 118 ml Kit Carton
Tukol ®
HONEY
Day Time
Multi symptom
VALUE PACK
COLD & FLU
Acetaminophen/ Dextromethorphan HBr /
Phenylephrine HCl
Ages
12+
NATURAL
HONEY
FLAVOR
Relieves:
- HEADACHE, SORE THROAT, FEVER
- MINOR ACHES AND PAINS
- NASAL CONGESTION AND COUGH
4 FL OZ (118 ml)
Night Time
Multi symptom
Acetaminophen/ Dextromethorphan HBr /
Doxylamine succinate
Ages
12+
NATURAL
HONEY
FLAVOR
Relieves:
- HEADACHE, SORE THROAT, FEVER
- MINOR ACHES AND PAINS
- SNEEZING, RUNNY NOSE
- COUGH
4 FL OZ (118 ml)
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2637726 | {1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution) } Pack | GPCK | 8 |
| 2637726 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution) Pack | PSN | 8 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 8 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 8 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 8 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 8 |
| 2637726 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 mL Oral Solution) Pack | SY | 8 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 8 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 8 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 8 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 8 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | 8 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 8 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50066-304-02 | 2024-01-11 | C162847 | 48780-1 | d6a99b39-e24a-a426-e053-dadaa90af4c2 | Tukol ® Honey Daytime & Nighttime Value Pack |
| 50066-304-02 | 2023-07-28 | C162847 | 48780-1 | d6a99b39-e24a-a426-e053-dadaa90af4c2 | Tukol ® Honey Daytime & Nighttime Value Pack |
| 50066-304-02 | 2023-01-27 | C162847 | 48780-1 | d6a99b39-e24a-a426-e053-dadaa90af4c2 | Tukol ® Honey Daytime & Nighttime Value Pack |
| 50066-304-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e24a-a426-e053-dadaa90af4c2 | Tukol ® Honey Daytime & Nighttime Value Pack |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50066-302-04 | Tukol Honey Daytime and Nighttime Value Pack | 118 mL in 1 BOTTLE, PLASTIC | SYRUP | 118 mL | 21.667 mg in 1mL | 8 |
| 50066-302-04 | Tukol Honey Daytime and Nighttime Value Pack | 1 in 1 CARTON | SYRUP | 21.667 mg in 1mL | 8 | |
| 50066-303-04 | Tukol Honey Daytime and Nighttime Value Pack | 118 mL in 1 BOTTLE, PLASTIC | SYRUP | 118 mL | 0.4167 mg in 1mL | 8 |
| 50066-303-04 | Tukol Honey Daytime and Nighttime Value Pack | 1 in 1 CARTON | SYRUP | 21.667 mg in 1mL | 8 | |
| 50066-304-02 | Tukol Honey Daytime and Nighttime Value Pack | 1 in 1 CARTON | KIT | 1 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50066-302 | TUKOL HONEY DAYTIME AND NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [GENOMMA LAB USA] | 8 | Current NDC, Legacy NDC | 20241024_bccc11d2-d227-4cbb-b0fc-ac6abb6dce57.zip |
| 50066-303 | TUKOL HONEY DAYTIME AND NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [GENOMMA LAB USA] | 8 | Current NDC, Legacy NDC | 20241024_bccc11d2-d227-4cbb-b0fc-ac6abb6dce57.zip |
| 50066-304 | TUKOL HONEY DAYTIME AND NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [GENOMMA LAB USA] | 8 | Current NDC, Legacy NDC, 5 package rows | 20241024_bccc11d2-d227-4cbb-b0fc-ac6abb6dce57.zip |
Products#
Every source-derived product name is available through these pages.
- Tukol Honey Daytime and Nighttime Value Pack
- Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, and Doxylamine Succinate
- Tukol Honey Daytime Cold and Flu
- Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
- ANHYDROUS CITRIC ACID
- FD&C YELLOW NO. 6
- HONEY
- WATER
- GLYCERIN
- PROPYLENE GLYCOL
- SORBITOL
- SODIUM BENZOATE
- SUCRALOSE
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- Tukol Honey Nighttime Cold and Flu
- Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50066-304 | 50066-304-02 |
| 50066-302 | 50066-302-04 |
| 50066-303 | 50066-303-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 Honey Daytime and Nighttime Value Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE | Genomma Lab USA | bccc11d2-d227-4cbb-b0fc-ac6abb6dce57 | 2024-10-22 | Warnings | 50066-304-02 50066-303-04 50066-302-04 50066-304 50066030204 50066030304 50066030402 2515ef33-47b2-13f8-e063-6394a90ada72 bccc11d2-d227-4cbb-b0fc-ac6abb6dce57 |
| Tukol Honey Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA | c9572b16-8e28-4f98-bd87-8a07721a49c6 | 2024-10-21 | Warnings | 50066-302-04 50066-302 50066030204 |
| Tukol Honey Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Genomma Lab USA | bf25f38e-3549-4f78-be90-46605b5f2c11 | 2024-10-21 | Warnings | 50066-303-04 50066-303 50066030304 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.