TUKOL CHILDRENS COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup

Tukol Childrens Cold and Flu by

Drug Labeling and Warnings

Tukol Childrens Cold and Flu 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 10 mL or 2 teaspoonful)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 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 your child takes:

• more than 5 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen.

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 more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomitting, 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 a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• persistent or chronic cough such as occurs with asthma
• cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin.

When using this product

• do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur
• redness or swelling is present
• pain, nasal congestion or cough gets worse or lasts more than 5 days
• new symptoms occur
• fever gets worse or lasts more than 3 days
• cough comes back, or occurs with rash or headache that lasts

These could be signs of a serious condition.

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 (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

• do not give more than directed (see Overdose warning)
• product not labeled with directions or warnings for adult use
• do not give more than 5 doses in any 24-hour period
• do not give more than 5 days unless directed by a doctor
• measure only with dosing cup provided
• dose as follows or as directed by a doctor
• mL=milliliter, tsp=teaspoonful as bulleted statement.

Age	Dose
Children 6 to under 12 years of age	10 mL or 2 tsp every 4 hours
Children under 6 years of age	do not use

Other information

• each 10 mL contains: sodium 6 mg
• store between 20-25°C (68-77°F), do not refrigerate
• keep carton for complete Drug facts

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?

Call 1-877-994-3666

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

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

NEW LOOK

Tukol®
CHILDREN'S

COLD & FLU

Acetaminophen / Dextromethorphan
HBr / Guaifenesin/Phenylephrine HCL

Ages
6-11

flavor
BERRIES

Relieves:

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

4 FL OZ (118 ml)

INGREDIENTS AND APPEARANCE

TUKOL CHILDRENS COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-315
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	1.0 mg  in 1 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	20.0 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	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-315-04	1 in 1 CARTON	01/17/2023
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 final	part341	01/17/2023

Labeler - Genomma Lab USA (832323534)