FDA Label for Tukol Honey Daytime And Nighttime Value Pack
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- LIVER WARNING
- ALLERGY ALERT
- SORE THROAT WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 118 ML KIT CARTON
Tukol Honey Daytime And Nighttime Value Pack 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.
Other
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
- sore throat
- headache
- minor aches and pain
- fever
- runny nose and sneezing
- cough due to minor throat and bronchial irritation
Temporarily relieves cold/flu symptoms:
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.
- 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
Allergy Alert
Acetaminophen may cause severe skin reactions. Symptoms may include
- skin reddening
- blisters
- rash.
- 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
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.
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.
If pregnant or breast feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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.
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
- 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 4 hours |
Children under 12 years | Do not use |
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
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
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
- HEADACHE, SORE THROAT, FEVER
- MINOR ACHES AND PAINS
- SNEEZING, RUNNY NOSE
- COUGH
4 FL OZ (118 ml)
Night Time
Multi symptom
Acetaminophen/ Dextromethorphan HBr /
Doxylamine succinate
Ages
12+
NATURAL
HONEY
FLAVOR
Relieves:
4 FL OZ (118 ml)
* Please review the disclaimer below.