Label: TUKOL MAX ACTION COLD, FLU AND SORE THROAT- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup
- NDC Code(s): 50066-313-06
- Packager: Genomma Lab USA
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 14, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
Liver warning
This product contains acetaminophen.
Severe liver damage may occur if you take:
- more than 4 doses (20 mL each) in 24 hours, which is the maximum daily amount for this product.
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product.
Allergy alert
Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening, blisters and 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 vominting, 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 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.
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- a breathing problem such as chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma chronic, bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to enlarged prostate gland
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- pain, nasal congestion or cough gets worse or lasts more than 7 days
- cough comes back or occuurs with fever, rash, or headache that lasts
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur.
These could be signs of a serious condition.
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Directions
- do not take more than directed
- Do not take more than 4 doses in 24 hours.
- This adult strength product is not intended for use in children under 12 years of age
- Dose as follows or as directed by a doctor
- Use dose cup provided
age dose adults and children 12 years and older 20 mL every 4 hours children under 12 years of age do not use - Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 177 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
TUKOL MAX ACTION COLD, FLU AND SORE THROAT
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50066-313 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 32.5 mg in 1 mL Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 1 mg in 1 mL Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 20 mg in 1 mL Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 0.5 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) Product Characteristics Color BLUE Score Shape Size Flavor MENTHOL (Characteristic medicinal) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50066-313-06 1 in 1 CARTON 06/21/2024 1 177 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 06/21/2024 Labeler - Genomma Lab USA (832323534)