TUKOL HONEY DAYTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride syrup

Tukol Honey Daytime Cold and Flu by

Drug Labeling and Warnings

Tukol Honey Daytime 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 30 mL)	Purpose
Acetaminophen 650 mg	Pain reliever/Fever reducer
Dextromethorphan HBr 20 mg	Cough suppressant
Phenylephrine HCl 10 mg	Nasal Decongestant

Uses

Temporarily relieves cold/flu symptoms:

• minor aches and pain
• headache
• sore throat
• nasal congestion
• cough due to minor throat and bronchial irritation
• temporarily reduces fever

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)

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 (see overdose warning)
• avoid alcoholic drinks

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.

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 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.

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

• each 30 mL contains sodium: 18 mg
• store between 15-30 oC (59-86 oF)
• do not refrigerate

Inactive ingredients

Citric acid, FD&C Yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions or comments?

1-877-994-3666 Monday to Friday from 8 am to 6 pm, Central Time.

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Distributed by
Genomma Lab USA Inc.,
Houston, TX 77098

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

Day Time

Tukol ®

HONEY MULTI SYMPTOM

COLD & FLU

Acetaminophen / Dextromethorphan HBr
/ Phenylephrine HCl

Ages
12+

NATURAL
HONEY
FLAVOR

Relieves:

• HEADACHE, SORE THROAT, FEVER
• MINOR ACHES AND PAINS
• NASAL CONGESTION AND COUGH

4 FL OZ (118 ml)

INGREDIENTS AND APPEARANCE

TUKOL HONEY DAYTIME COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride syrup

Product 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)