FDA Label for Tukol Honey Daytime Cold And Flu
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?
- PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE CARTON
Tukol Honey Daytime 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.
Other
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 |
Uses
Temporarily relieves cold/flu symptoms:
- minor aches and pain
- headache
- sore throat
- fever
- nasal congestion
- 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
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
- 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
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
- 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.
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 (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
- 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.
age | dose |
---|---|
adults and children 12 years and over | 30 mL every 4 hours |
Children under 12 years | Do not use |
Other Information
- each 15 mL contains sodium: 5 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?
1-877-994-3666
Principal Display Panel - 118 Ml Bottle Carton
NEW
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)
* Please review the disclaimer below.