FDA Label for Tukol Honey Nighttime Cold And Flu

View Indications, Usage & Precautions

Tukol Honey Nighttime Cold And Flu Product Label

The following document was submitted to the FDA by the labeler of this product Genomma Lab Usa. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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Cold & Flu Day Time Multi-Symptom Relief with Natural Honey

Drug Facts

Cold & Flu Night Time Multi-Symptom Relief with Natural Honey

Drug Facts

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

Otc - Purpose

Active Ingredients (in each 15 mL)	Purpose
Acetaminophen 325 mg	Pain reliever/Fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Phenylephrine HCl 5 mg	Nasal Decongestant

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 cold/flu symptoms:

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

Temporarily relieves cold/flu symptoms:

sore throat
headache
minor aches and pain
fever
runny nose and sneezing
cough due to minor throat and bronchial irritation

Liver Warning

The product contains Acetaminophen. Severe liver damage may occur if you take

more than 4 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.

The product contains Acetaminophen. Severe liver damage may occur if you take

more than 4 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 skin reaction occurs, stop use and seek medical help right away.

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

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.
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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
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)

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 the blood thinning drug warfarin

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 (see overdose warning)
avoid alcoholic drinks

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

you get nervous, dizzy or sleepless
new symptoms occur
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. These could be signs of a serious condition.

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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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 noticve any signs or symptoms.

Directions

take only as recommended (see Overdose warning)
use dosage cup
do not exceed 4 doses per 24 hours

Adults and children 12 years and over	30 mL 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.

take only as recommended see Overdose warning
use dosage cup
do not exceed 4 doses per 24 hours
If taking Night Time at night and Day Time during the day, limit total to 4 doses per 24 hours.

Adults and children 12 years and over	30 mL every 6 hours
Children 4 to under 12 years	Ask a doctor
Children under 4 years	Do not use

Other Information

Each 15 mL contains sodium: 5 mg
store at room temperature

Each 30 mL contains sodium 10 mg
store at room temperature

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

Principal Display Panel - 118 Ml Kit Carton

NEW

Tukol^®
HONEY

Day Time
Multi symptom

VALUE PACK
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)

Night Time
Multi symptom

Acetaminophen/ Dextromethorphan HBr /
Doxylamine succinate