TUKOL A- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
Genomma Lab USA, Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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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
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.
taking any other oral nasal decongestant or stimulant.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
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
citric acid, FD and C Blue # 1, FD and C Red # 40, flavor, glycerin, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
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®
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
2FTAP1MUEWW1B
TUKOL A
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid |
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Labeler - Genomma Lab USA, Inc. (832323534) |
Registrant - AptaPharma Inc. (790523323) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
AptaPharma Inc. | 790523323 | manufacture(50066-536) |