NDC | 50066-533-24 |
Set ID | b9d32964-5bd7-44b0-be98-827d5310ed4f |
Category | HUMAN OTC DRUG LABEL |
Packager | Genomma Lab USA, Inc. |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- DRUG FACTSActive ingredients(in each 5 mL tsp)
- Purposes
- KEEP OUT OF REACH OF CHILDREN
- Uses
-
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.
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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
- If pregnant or breast-feeding
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
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
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INGREDIENTS AND APPEARANCE
TUKOL X-PECTO MIEL MULTI SYMPTOM COLD
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquidProduct 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)