TUKOL MAX ACTION SINUS LIQUID- acetaminophen, guaifenesin, and phenylephrine hydrochloride syrup

Tukol Max Action Sinus Liquid by

Drug Labeling and Warnings

Tukol Max Action Sinus Liquid by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 20 mL)	Purposes
Acetaminophen 650mg	Pain reliever
Guaifenesin 400 mg	Expectorant
Phenylephrine HCl 10 mg	Nasal decongestant

Uses

temporarily relieves:

• nasal congestion
• headache
• minor aches and pains
• sinus congestion and pressure
• temporarily promotes nasal and sinus drainage
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

Liver warning

This product contains acetaminophen.

Severe liver damage may occur if you take:

• more than 6 doses 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 a skin reaction occurs, stop use and seek medical help right away.

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 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.
• for children under 12 years of age

Ask a doctor before use if you have

• liver disease
• heart disease
• thyroid disease
• high blood pressure
• diabetes
• trouble urinating due to an enlarged prostate gland
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
• cough that occurs with too much 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

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur
• 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 persistent headache. 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• take only as recommended (see Overdose warning)
• use dosage cup
• mL = milliliter
• do not take more than 6 doses in any 24-hour period

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
• dosage cup provided
• store between 15-30°C (59-86°F)
• do not refrigerate

Inactive ingredients

Anhydrous citric acid, edetate disodium, FD&C yellow no. 6, flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions?

Call weekdays from 8 AM to 6 PM EST at 1-877-994-3666

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Distributed by:
Genomma Lab USA Inc.,
Houston, TX 77027

PRINCIPAL DISPLAY PANEL - 177 ml Bottle Carton

NEW

Tukol®

MAX ACTION

SINUS

Headache and Congestion

Acetaminophen / Guaifenesin / Phenylephrine HCl

For Ages
12 & Over

NATURAL
GINGER FLAVOR

• ♦ SINUS CONGESTION
• ♦ HEADACHE
• ♦ EXPECTORANT

6 FL OZ (177 ml)

INGREDIENTS AND APPEARANCE

TUKOL MAX ACTION SINUS LIQUID 
acetaminophen, guaifenesin, and phenylephrine hydrochloride syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-305
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
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	YELLOW (Amber to yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-305-06	1 in 1 CARTON	07/30/2021
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 FINAL	part341	07/30/2021

Labeler - Genomma Lab USA (832323534)