TUKOL HONEY DAYTIME AND NIGHTTIME VALUE PACK- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and doxylamine succinate 
Genomma Lab USA

----------

Tukol® Honey Daytime & Nighttime Value Pack

Cold & Flu Day Time Multi-Symptom Relief with Natural Honey

Drug Facts

Active Ingredients (in each 30 mL)Purpose
Acetaminophen 650 mgPain reliever/Fever reducer
Dextromethorphan HBr 20 mgCough suppressant
Phenylephrine HCl 10 mgNasal Decongestant

Uses

Temporarily relieves these common cold and flu symptoms

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.

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

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

Adults and children 12 years or age and over30 mL (2 tablespoons) every 4 hours
Children under 12 yearsDo not use
  • When using Day Time and Night Time products, carefully read each label to ensure correct dosing.

Other information

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

Cold & Flu Night Time Multi-Symptom Relief with Natural Honey

Drug Facts

Active Ingredients (in each 30 mL)Purpose
Acetaminophen 650 mgPain reliever/Fever reducer
Dextromethorphan HBr 30 mgCough suppressant
Doxylamine Succinate 12.5 mgAntihistamine

Uses

Temporarily relieves these common cold and flu symptoms:

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.

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

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

Adults and children 12 years of age and over30 mL (2 tablespoons) every 6 hours
Children under 12 years of ageDo not use

when using day time and night time products, carefully read each label to ensure correct dosing

Other information

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.

Distributed by:
Genomma Lab USA Inc.,
Houston, TX 77098

PRINCIPAL DISPLAY PANEL - 118 ml Kit Carton

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:

4 FL OZ (118 ml)

Night Time
Multi symptom

Acetaminophen/ Dextromethorphan HBr /
Doxylamine succinate

Ages
12+

NATURAL

HONEY
FLAVOR

Relieves:

4 FL OZ (118 ml)

TUKOL HONEY DAYTIME AND NIGHTTIME VALUE PACK 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and doxylamine succinate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-304
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-304-021 in 1 CARTON01/30/2023
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 118 mL
Part 21 BOTTLE, PLASTIC 118 mL
Part 1 of 2
TUKOL HONEY DAYTIME COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride syrup
Product Information
Item Code (Source)NDC:50066-302
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen21.667 mg  in 1 mL
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide0.667 mg  in 1 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride0.333 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HONEY (UNII: Y9H1V576FH)  
WATER (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Sorbitol (UNII: 506T60A25R)  
Sodium benzoate (UNII: OJ245FE5EU)  
Sucralose (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorYELLOW (Amber to yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-302-041 in 1 CARTON
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/02/2020
Part 2 of 2
TUKOL HONEY NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate syrup
Product Information
Item Code (Source)NDC:50066-303
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen21.667 mg  in 1 mL
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide1 mg  in 1 mL
Doxylamine Succinate (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) Doxylamine Succinate0.4167 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HONEY (UNII: Y9H1V576FH)  
WATER (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Sorbitol (UNII: 506T60A25R)  
Sodium benzoate (UNII: OJ245FE5EU)  
Sucralose (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorYELLOW (Amber to yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-303-041 in 1 CARTON
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01201/30/2023
Labeler - Genomma Lab USA (832323534)

Revised: 1/2024
Document Id: 9b0c036b-c277-4b21-a62d-fcd16aed3961
Set id: bccc11d2-d227-4cbb-b0fc-ac6abb6dce57
Version: 6
Effective Time: 20240111
 
Genomma Lab USA