TUKOL MULTI SYMPTOM COLD - 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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Active ingredients

DRUG FACTS


Active ingredients
(in each 5 mL tsp)
Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg
Phenylephrine HCL, USP 5 mg

Purposes

Cough Suppressant
Expectorant
Nasal Decongestant

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 right away.

Uses

Warnings

Do not use

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.

Ask a doctor before use Ask a doctor or pharmacist before use

Ask a doctor before use if you have




Ask a doctor or pharmacist before use if you are

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

These could be signs of a serious condition.

If pregnant or breast-feeding

ask a health professional before use.

Directions


Age - adults and children 12 years and over    Dose - 2 teaspoons every 4 hours

Age - children under 12    Dose - do not use

Other information

Inactive ingredients

anhydrous citric acid, FD and C red no. 40, glycerin, menthol, natural and artificial flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions or comments?

1 877 99 GENOM (43666)

Product Label Tukol 504 DPL

Tukol®

DO NOT USE IF PRINTED SEAL UNDER CAP

IS TORN OR MISSING

Dextromethorphan HBr / Guaifenesin / Phenylephrine HCL

Expectorant/Cough Suppressant/Nasal Decongestant

Tukol®

Cough & Congestion

Ages/ 12+    4 FL OZ (118 mL)

2000005853

6  50066 00012  6

LOT No.
Exp.

Distributed by
Genomma Lab USA Inc.

Houston, TX 77027

BX-006  Rev. 03

Genoma Lab.®

Tukpl 504-24 Box RV3

Tukpl 504-24 Botl RV3

rege

TUKOL MULTI SYMPTOM COLD  
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-504
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL (UNII: L7T10EIP3A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-504-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/15/2012
Labeler - Genomma Lab USA, Inc. (832323534)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(50066-504)

Revised: 8/2019
Document Id: d97ef49f-3c56-4996-8075-a7a5ac28aced
Set id: aef2ad43-145d-4abc-bccc-2c5fdd6882f9
Version: 5
Effective Time: 20190821
 
Genomma Lab USA, Inc.