Label: TUKOL HONEY DAYTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride syrup
- NDC Code(s): 50066-302-04
- Packager: Genomma Lab USA
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 11, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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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.
Overdose warning
Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
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Directions
- do not take mare than directed
- do not take more than 4 doses in any 24 hours
- this adult strength product is not inteded for use in children under 12 years of age
- measyre only with dosing cup provided
- keep dosing cup with product
- mL = mililiter
- TBSP = tablespoon
- dose as follows
age dose adults and children 12 years of 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
- PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
TUKOL HONEY DAYTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride syrupProduct Information Product Type HUMAN OTC DRUG 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 Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Propylene Glycol (UNII: 6DC9Q167V3) Sorbitol (UNII: 506T60A25R) Sodium benzoate (UNII: OJ245FE5EU) Sucralose (UNII: 96K6UQ3ZD4) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HONEY (UNII: Y9H1V576FH) 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 02/09/2020 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 02/09/2020 Labeler - Genomma Lab USA (832323534)