FDA Label for Tukol Day Time Cold And Flu Relief Softgels
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 IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 24 SOFTGEL BLISTER PACK CARTON
Tukol Day Time Cold And Flu Relief Softgels 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 77098
Otc - Purpose
Active ingredients (in each softgel) | Purpose |
---|---|
Acetaminophen 325 mg | Pain reliever/fever reducer |
Dextromethorphan HBr 10 mg | Cough suppressant |
Phenylephrine HCl 5 mg | Nasal decongestant |
Uses
temporarily relieves common cold and flu symptoms:
- nasal congestion
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches and pains
- fever
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hours, which is the maximum daily amount
- 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 products 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 drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
When Using This Product
- do not exceed recommended dosage
Stop Use And Ask A Doctor If
- you get nervous, dizzy or sleepless
- symptoms get worse or last more than 5 days (children) or 7 days (adults)
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts.
- a skin reaction occurs. These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use
Directions
- take only as directed (see Warnings)
- do not exceed 4 doses per 24 hours
Adults and children 12 years and over: take 2 softgels with water every 4 hours
Children 4 to under 12 years: Ask a doctor
Children under 4 years: Do not use - When using Day Time or Night Time products, carefully read each label to ensure correct dosing
Other Information
- store at room temperature 20-25°C (68-77°F)
Inactive Ingredients
FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol, Purified Water, Sorbitol sorbitan solution, Titanium dioxide.
Questions Or Comments?
Call toll free 1-877-994-3666
Weekdays from 8 am to 6 pm
Principal Display Panel - 24 Softgel Blister Pack Carton
NEW
Non Drowsy
Tukol®
DAY TIME
COLD AND FLU RELIEF
Acetaminophen / Dextromethorphan HBr /
Phenylephrine HCl
- COUGH
- FEVER
- SORE THROAT
- ACHES
- NASAL CONGESTION
24 Softgels
* Please review the disclaimer below.