TUKOL X-PECTO MIEL  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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Tukol® X-PECTO MIEL Cough & Cold  533

DRUG FACTSActive 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.

 In case of overdose, get medical help or contact a Poison Control Center right away.

Uses

     • nasal congestion

     • cough due to minor throat and bronchial irritation

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 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.

Ask a doctor before use if you have

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 yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

1 877 99 GENOM (43666)

Monday to Friday from 8 am to 6 pm, Central time.

Tukol X-PECTO MIEL Cough & Cold product label

Tukol®

X-PECTO MIEL

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Dextromethorphan HBr / Guaifenesin / Phenylephrine HCL

Cough Suppressant / Expectorant / Nasal Decongestant

Tukol®

X-PECTO MIEL

Cough & Cold

NATURAL HONEY FLAFOR
Ages / 12+   4 FL OZ (118 ml)

2000006935

6  50066 00042  0

LOT no.

Exp.

Distributed by Genomma Lab USA Inc.

Houston TX, 77027

BX-035 Rev. 02

Genomma Lab.®

Tokul X-PECTO 533-24 Box VER2

Tokul X-PECTO 533-24 Btl VER2

rege

TUKOL X-PECTO MIEL   MULTI SYMPTOM COLD
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-533
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 YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
HONEY (UNII: Y9H1V576FH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorHONEY (HONEY) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-533-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/15/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/15/2013
Labeler - Genomma Lab USA, Inc. (832323534)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(50066-533)

Revised: 8/2019
Document Id: 58c626be-30c0-4482-ac84-3bac155aa308
Set id: b9d32964-5bd7-44b0-be98-827d5310ed4f
Version: 4
Effective Time: 20190821
 
Genomma Lab USA, Inc.