TUKOL X-PECTO MIEL MULTI SYMPTOM COLD- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

Tukol X-Pecto Miel by

Drug Labeling and Warnings

Tukol X-Pecto Miel 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 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

Keep out of reach of children.

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

Uses

• help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
• temporarily relieves these symptoms occurring with a cold

     nasal congestion

     cough due to minor throat and bronchial irritation

WARNINGS

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 DOCTOR/PHARMACIST

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

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• 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

• 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 health professional before use.

Directions

• Do not take more than 6 doses in any 24 hour period
• This adult strength product is not intended for use in children under 12 years of age

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

Age - children under 12    Dose - do not use

Other information

• each teaspoon contains: sodium 3 mg
• store at 20‐25 ° C (68‐77 ° F). Do not refrigerate.
• dosage cup provided

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

• Quiets Cough
• Thins & loosens Phlegm
• Clears Nasal Congestion

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.®

rege

INGREDIENTS AND APPEARANCE

TUKOL X-PECTO MIEL   MULTI SYMPTOM COLD
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-533
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  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	HONEY (HONEY)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-533-24	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/15/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/15/2013

Labeler - Genomma Lab USA, Inc. (832323534)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(50066-533)