TUKOL MAX ACTION COLD, FLU AND SORE THROAT- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup

Tukol Max Action Cold, Flu and Sore Throat by

Drug Labeling and Warnings

Tukol Max Action Cold, Flu and Sore Throat 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

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 20 mL)	Purposes
Acetaminophen 650mg	Pain reliever/fever reducer
Dextromethorphan HBr 20 mg	Cough suppressant
Guaifenesin 400 mg	Expectorant
Phenylephrine HCl 10 mg	Nasal decongestant

Uses

• temporarily relieves these common cold and flu symptoms:
  • nasal congestion
  • cough
  • minor aches and pains
  • sore throat
  • headache
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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

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

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.

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

Keep out of reach of children.

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. Quick medical attention is critical even if you do not notice any signs or symptoms.

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

• each 20 mL contains: sodium 10 mg
• store between 15-30°C (59-86°F), do not refrigerate

Inactive ingredients

Anhydrous citric acid, edetate disodium, FD&C Blue # 1, FD&C Red # 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

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 77027

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Carton

Tukol®
MAX ACTION

COLD, FLU AND SORE THROAT

Acetaminophen / Dextromethorphan HBr/
Guaifenesin / Phenylephrine HCl

Ages
12+

MAX
STRENGTH

Relieves:

• MINOR ACHES & PAIN
• FEVER
• NASAL & CHEST CONGESTION
• COUGH

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

TUKOL MAX ACTION COLD, FLU AND SORE THROAT 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup

Product 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)