TUKOL MAXIUM STRENGTH COUGH AND MUCUS RELIEF - dextromethorphan hydrobromide, guaifenesin capsule, gelatin coated 
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

Dextromethorphan HBr 10 mg
Guaifenesin 200 mg

Purpose

Cough Suppressant
Expectorant

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 if you have

Stop use and ask a doctor if

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.

If pregnant or breast-feeding

ask a health professional before use.

Directions

Other information

Inactive ingredients

FD and C Red # 40, Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol, Purified water, Sorbitol sorbitan solution, Titanium dioxide

Questions or comments?

1-877-99 GENOM (43666)

Tukol Maximum Strength Cough and Mucus Relief Label

Tukol®

Dextromethorphan HBr-Cough suppressant / Guaifensin-Expectorant

Relieves

Cough
Mucus

Use in the morning, evening or anytime

MAIMUM STRENGTH

For ages 12 and over

20 SOFTGELS

Do not use if plastic blister is open or broken

Made in India
Distributed by Genomma Lab USA, Inc. Houston, TX 77027

BX - 048


AptaPharma TukolMS Label

AptaPharma TukolMS1 Label

TUKOL MAXIUM STRENGTH COUGH AND MUCUS RELIEF 
dextromethorphan hydrobromide, guaifenesin capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-601
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorred (RED) Scoreno score
ShapeCAPSULE (OBLONG) Size20mm
FlavorImprint Code 601
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-601-0220 in 1 CARTON
11 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/17/2015
Labeler - Genomma Lab USA, Inc (832323534)
Registrant - AptaPharma Inc (790523323)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc790523323manufacture(50066-601) , relabel(50066-601) , repack(50066-601)

Revised: 3/2015
Document Id: fa673d33-89b9-40b9-adc3-6c0c6ca420e8
Set id: ae5ce270-ca7b-4a6e-bc48-547e97db06e1
Version: 1
Effective Time: 20150311
 
Genomma Lab USA, Inc