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

Tukol Maxium Strength Cough and Mucus Relief by

Drug Labeling and Warnings

Tukol Maxium Strength Cough and Mucus Relief by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA, Inc, AptaPharma Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  

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

• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
  

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

• Do not take more than 12 softgels in any 24-hour period
• This product is not intended for use in children under 12 years
• Adults and children 12 years and over - 2 softgels every 4 hours
• Children under 12 years of age - do not use
  

Other information

• Store at room temperature
• Avoid excessive heat above 40° C (104° F)
  

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-601
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	red (RED)	Score	no score
Shape	CAPSULE (OBLONG)	Size	20mm
Flavor		Imprint Code	601
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-601-02	20 in 1 CARTON
1		1 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/17/2015

Labeler - Genomma Lab USA, Inc (832323534)

Registrant - AptaPharma Inc (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc		790523323	manufacture(50066-601) , relabel(50066-601) , repack(50066-601)