NDC | 50066-536-24 |
Set ID | 651f0d7c-c76b-434d-95fd-427609b40b46 |
Category | HUMAN OTC DRUG LABEL |
Packager | Genomma Lab USA, Inc. |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Active ingredients
- Purpose
- Uses
-
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
- 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®
Cough Suppressant/Expectorant/Nasal Decongestant
Dextromethorphan HBr | Guaifenesin | Phenylephrine HCIAges 4+
Cough and Cold
Gets rid of phlegm
Quiets Cough
Clears nasal congestionGrape 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 decongestantUses
• 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 irritationWarnings
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 directedStop 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 = milliliterage 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 useOther information
• each 5 mL contains: sodium 3 mg
• store at room temperatureInactive 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 HCIDO NOT USE IF PRINTED SEAL UNDER CAP
IS TORN OR MISSINGChildren’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 congestionGrape 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 decongestantUses
• 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 irritationWarnings
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 directedStop 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
8/17Drug Facts (continued)
Directions
• do not exceed 6 doses in a 24-hour period
• use enclosed dosage cup
• tsp = teaspoon, mL = milliliterage 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 useOther information
• each 5 mL contains: sodium 3 mg
• store at room temperatureInactive 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 -
INGREDIENTS AND APPEARANCE
TUKOL A
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50066-536 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 50 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor GRAPE (GRAPE FLAVOR) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50066-536-24 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/09/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/09/2014 Labeler - Genomma Lab USA, Inc. (832323534) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(50066-536)