TUKOL HONEY DAYTIME AND NIGHTTIME VALUE PACK- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and doxylamine succinate kit
Tukol Honey Daytime and Nighttime Value Pack by
Drug Labeling and Warnings
Tukol Honey Daytime and Nighttime Value Pack by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
-
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)
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.
-
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 - When using Day Time and Night Time products, carefully read each label to ensure correct dosing.
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
-
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.
-
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
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 118 ml Kit Carton
Tukol ®
HONEY
Day Time
Multi symptomVALUE PACK
COLD & FLUAcetaminophen/ Dextromethorphan HBr /
Phenylephrine HClAges
12+NATURAL
HONEY
FLAVORRelieves:
- HEADACHE, SORE THROAT, FEVER
- MINOR ACHES AND PAINS
- NASAL CONGESTION AND COUGH
4 FL OZ (118 ml)
Night Time
Multi symptomAcetaminophen/ Dextromethorphan HBr /
Doxylamine succinateAges
12+NATURAL
HONEY
FLAVORRelieves:
- HEADACHE, SORE THROAT, FEVER
- MINOR ACHES AND PAINS
- SNEEZING, RUNNY NOSE
- COUGH
4 FL OZ (118 ml)
-
INGREDIENTS AND APPEARANCE
TUKOL HONEY DAYTIME AND NIGHTTIME VALUE PACK
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and doxylamine succinate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 50066-304 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 50066-304-02 1 in 1 CARTON 01/30/2023 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 118 mL Part 2 1 BOTTLE, PLASTIC 118 mL Part 1 of 2 TUKOL HONEY DAYTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride syrupProduct Information Item Code (Source) NDC: 50066-302 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 21.667 mg in 1 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 0.667 mg in 1 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 0.333 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color yellow (Amber to yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 50066-302-04 1 in 1 CARTON 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 09/02/2020 Part 2 of 2 TUKOL HONEY NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate syrupProduct Information Item Code (Source) NDC: 50066-303 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 21.667 mg in 1 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 1 mg in 1 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 0.4167 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color yellow (Amber to yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 50066-303-04 1 in 1 CARTON 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 09/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 01/30/2023 Labeler - Genomma Lab USA (832323534)
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