TUKOL MAX ACTION SEVERE CONGESTION AND COUGH- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Tukol MAX ACTION Severe Congestion and Cough by

Drug Labeling and Warnings

Tukol MAX ACTION Severe Congestion and Cough by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug FactsActive ingredients(in each 20 mL)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCL 10 mg

Purpose

Cough suppressant
Expectorant
Nasal decongestant

Uses

• Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
• temporarily relieves these symptoms occuring with a cold
• cough due to minor throat and bronchial irritation
• nasal congestion

Warnings

Do not use

• for children under 12 years of age
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatic, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping an 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

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
• trouble urinating due to enlarged prostate gland

When using this product

When using this product do not use more than directed

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• symptoms do not get better within 7 days or are accompanied by fever
• 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 professional before use

Keep out of reach of children

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

Directions

• Do not take more than 6 doses in any 24 hours
• Use dose cup provided

Age                                                       Dose
Adults and children
12 years and older                                20 mL every 4 hours

Children under 12 years of age            Do not use

Other information

• Each 20 mL contains: sodium 10 mg
• store between15-30°C (59-86 °F)
• do not refrigerate

Inactive Ingredients

Anhydrous citric acid, edetate disodium, FD&C Blue # 1, FD&C Red # 40, flavors, glycerin, propylene glycol, propyl gallate, Purified water, sodium benzoate, Sorbitol, sucralose, xanthan gum

Questions or comments?

1-877-99-Genom (43666)
Monday to Friday from 8 AM to 6 PM, Central time

Tukol MAX ACTION Severe Congestion & Cough product label

Tukol® MAX ACTION

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

NEW MAX STRENGTH

DEXTROMETHORPHAN HBr/GUAIFENESIN/PHENYLEPHRINE HCL

Tukol® MAX ACTION
Severe
CONGESTION & COUGH

• Clears Nasal & Chest Congestion
• Thins & Loosens Mucus
• Controls Cough

Ages 12+     6 FL OZ (177 mL)

Distributed by:
Genomma Lab USA, Inc.
Houston, TX 77027
Box number: BX-064

INGREDIENTS AND APPEARANCE

TUKOL MAX ACTION SEVERE CONGESTION AND COUGH 
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-517
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	10 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYL GALLATE (UNII: 8D4SNN7V92)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-517-25	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/16/2016

Labeler - Genomma Lab USA, Inc (832323534)

Registrant - AptaPharma Inc (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc		790523323	manufacture(50066-517) , relabel(50066-517) , repack(50066-517)