TUKOL HONEY NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate syrup

Tukol Honey Nighttime Cold and Flu by

Drug Labeling and Warnings

Tukol Honey Nighttime 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]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients (in each 30 mL)	Purpose
Acetaminophen 650 mg	Pain reliever/Fever reducer
Dextromethorphan HBr 30 mg	Cough suppressant
Doxylamine Succinate 12.5 mg	Antihistamine

Uses

Temporarily relieves these common cold and flu symptoms:

• sore throat
• headache
• minor aches and pain
• runny nose and sneezing
• 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) 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
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor.
• 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.
• to make a child sleepy

Ask a doctor before use if you have

• liver disease
• glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma chronic bronchitis or emphysema
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use

• if you are taking sedatives or tranquillizers
• if you are taking the blood thinning drug warfarin

When using this product

• do not use more than directed
• avoid alcoholic drinks
• excitability may occur, especially in children
• marked drowsiness may occur
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

• 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 headache that lasts. 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 may cause serious health problems. 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

• do not take more than directed
• do not take more than 4 doses in any 24 hours
• this adult strength product is not intended for use in children under 12 years of age
• measure 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 6 hours
Children under 12 years of age	do not use

when using day time and night time prodcuts, 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 8 am to 6 pm, Central Time

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

Night Time

Tukol ®
HONEY MULTISYMPTOM

COLD & FLU

Acetaminophen/ Dextromethorphan HBr /
Doxylamine succinate

Ages
12+

NATURAL

HONEY
FLAVOR

Relieves:

• HEADACHE, SORE THROAT, FEVER
• MINOR ACHES AND PAINS
• SNEEZING, RUNNY NOSE
• COUGH

4 FL OZ (118 ml)

INGREDIENTS AND APPEARANCE

TUKOL HONEY NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-303
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	1 mg  in 1 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	0.4167 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HONEY (UNII: Y9H1V576FH)
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: 50066-303-04	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)