FDA Label for Tukol Max Action Sinus Liquid
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- LIVER WARNING
- ALLERGY ALERT
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- 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 - 177 ML BOTTLE CARTON
Tukol Max Action Sinus Liquid 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 20 mL) | Purposes |
---|---|
Acetaminophen 650mg | Pain reliever |
Guaifenesin 400 mg | Expectorant |
Phenylephrine HCl 10 mg | Nasal decongestant |
Uses
temporarily relieves:
- nasal congestion
- headache
- minor aches and pains
- sinus congestion and pressure
- temporarily promotes nasal and sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Liver Warning
This product contains acetaminophen.
Severe liver damage may occur if you take:
- more than 6 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 a skin reaction occurs, stop use and seek medical help right away.
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 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.
- for children under 12 years of age
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- trouble urinating due to an enlarged prostate gland
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Otc - When Using
When using this product do not use more than directed
Stop Use And Ask A Doctor If
- nervousness, dizziness or sleeplessness occur
- 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 persistent headache. 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 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
- take only as recommended (see Overdose warning)
- use dosage cup
- mL = milliliter
- do not take more than 6 doses in any 24-hour period
Age | Dose |
---|---|
Adults and children 12 years and older | 20 mL every 4 hours |
Children under 12 years of age | Do not use |
Other Information
- each 20 mL contains: sodium 10 mg
- dosage cup provided
- store between 15-30°C (59-86°F)
- do not refrigerate
Inactive Ingredients
Anhydrous citric acid, edetate disodium, FD&C yellow no. 6, flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Questions?
Call weekdays from 8 AM to 6 PM EST at 1-877-994-3666
Principal Display Panel - 177 Ml Bottle Carton
NEW
Tukol®
MAX ACTION
SINUS
Headache and Congestion
Acetaminophen / Guaifenesin / Phenylephrine HCl
For Ages
12 & Over
NATURAL
GINGER FLAVOR
♦ SINUS CONGESTION♦ HEADACHE♦ EXPECTORANT
6 FL OZ (177 ml)
* Please review the disclaimer below.