FDA Label for Tukol A
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF THE CHILD HAS
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- CHILDREN'S TUKOL BOTTLE LABEL
- CHILDREN'S TUKOL BOX LABEL
Tukol A Product Label
The following document was submitted to the FDA by the labeler of this product Genomma Lab Usa, Inc.. 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.
Active Ingredients
DRUG FACTS
Active ingredients
(in each 5 mL, 1 teaspoon)
Dextromethorphan HBr, USP 5 mg
Guaifenesin, USP 50 mg
Phenylephrine HCL, USP 2.5 mg
Purpose
Cough Suppressant
Expectorant
Nasal Decongestant
Uses
- help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
- temporarily relieves these symptoms occurring with a cold - nasal congestion - cough due to minor throat and bronchial irritation
Warnings
Do not use in a child
who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If The Child Has
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- cough that lasts or is chronic such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If The Child Is
taking any other oral nasal decongestant or stimulant.
When Using This Product
- do not use more than directed
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occurs
- symptoms do not get better within 7 days or are accompanied by a fever
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache These could be signs of a serious condition.
Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Directions
age dose
children 6 to 12 years 2 tsp (10 mL) every 4 hours
children 4 to 6 years 1 tsp (5 mL) every 4 hours
children under 4 years do not use
- do not exceed 6 doses in a 24-hour period
- use enclosed dosage cup
- tsp = teaspoon, mL = milliliter
Other Information
- each 5 mL contains: sodium 3 mg
- store at room temperature
Inactive Ingredients
citric acid, FD and C Blue # 1, FD and C Red # 40, flavor, glycerin, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
1 877 99 GENOM (43666)
Children's Tukol Bottle Label
Children’s Tukol®
Cough Suppressant/Expectorant/Nasal Decongestant
Dextromethorphan HBr | Guaifenesin | Phenylephrine HCI
Ages 4+
Cough and Cold
Gets rid of phlegm
Quiets Cough
Clears nasal congestion
Grape Flavor
4 FL OZ (118 ml)
Drug Facts
Active ingredients Purpose
(in each 5 mL, 1 teaspoon)
Dextromethorphan HBr, 5 mg ...............Cough suppressant
Guaifenesin, 50 mg. .......................................Expectorant
Phenylephrine HCI, 2.5 mg ................... Nasal decongestant
Uses
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
• temporarily relieves these symptoms occurring with a cold:
• nasal congestion
• cough due to minor throat and bronchial irritation
Warnings
Do not use in a child who is 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.
Ask a doctor before use if the child has
• heart disease
• diabetes
• high blood pressure
• thyroid disease
• cough that lasts or is chronic such as occurs with asthma
• cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if the child is taking any other oral nasal decongestant or stimulant.
When using this product
• do not use more than directed
Stop use and ask a doctor if
• nervousness, dizziness, or sleeplessness occurs
• symptoms do not get better within 7 days or are accompanied by fever
• cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
Drug Facts (continued)
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Directions
• do not exceed 6 doses in a 24-hour period
• use enclosed dosage cup
• tsp = teaspoon, mL = milliliter
age dose
children 6 to 12 years 2 teaspoons (10 mL) every 4 hours
children 4 to 6 years 1 teaspoons (5 mL) every 4 hours
children under 4 years do not use
Other information
• each 5 mL contains: sodium 3 mg
• store at room temperature
Inactive ingredients citric acid, FD&C Blue # 1, FD&C Red # 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Questions or comments? 1-877-99 GENOM (43666)
Distributed by Genomma Lab USA., Houston, TX, 77027
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
LR-063 Rev. 2
PEEL HERE
Children's Tukol Box Label
Children’s Tukol®
Cough Suppressant/Expectorant/Nasal Decongestant
Dextromethorphan HBr | Guaifenesin | Phenylephrine HCI
DO NOT USE IF PRINTED SEAL UNDER CAP
IS TORN OR MISSING
Children’s Tukol®
Cough Suppressant/Expectorant/Nasal Decongestant
Dextromethorphan HBr | Guaifenesin | Phenylephrine HCI
Ages 4+
Cough and Cold
Gets rid of phlegm
Quiets Cough
Clears nasal congestion
Grape Flavor
4 FL OZ (118 ml)
LOT No.
Exp.
Drug Facts
Active ingredients Purpose
(in each 5 mL, 1 teaspoon)
Dextromethorphan HBr, 5 mg ...............Cough suppressant
Guaifenesin, 50 mg. .......................................Expectorant
Phenylephrine HCI, 2.5 mg ................... Nasal decongestant
Uses
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
• temporarily relieves these symptoms occurring with a cold:
• nasal congestion
• cough due to minor throat and bronchial irritation
Warnings
Do not use in a child who is 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.
Ask a doctor before use if the child has
• heart disease
• diabetes
• high blood pressure
• thyroid disease
• cough that lasts or is chronic such as occurs with asthma
• cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if the child is taking any other oral nasal decongestant or stimulant.
When using this product
• do not use more than directed
Stop use and ask a doctor if
• nervousness, dizziness, or sleeplessness occurs
• symptoms do not get better within 7 days or are accompanied by fever
• cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Distributed by
Genomma Lab USA Inc.,
Houston, TX 77027
Genomma Lab.®
3
66975-3
8/17
Drug Facts (continued)
Directions
• do not exceed 6 doses in a 24-hour period
• use enclosed dosage cup
• tsp = teaspoon, mL = milliliter
age dose
children 6 to 12 years 2 teaspoons (10 mL) every 4 hours
children 4 to 6 years 1 teaspoons (5 mL) every 4 hours
children under 4 years do not use
Other information
• each 5 mL contains: sodium 3 mg
• store at room temperature
Inactive ingredients citric acid, FD&C Blue # 1, FD&C Red # 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Questions or comments? 1-877-99 GENOM (43666)
BX-037 Rev. 02
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