Label: TUKOL MULTI SYMPTOM COLD- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
- NDC Code(s): 50066-504-24
- Packager: Genomma Lab USA, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated August 21, 2019
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- Active ingredients
- Purposes
- Keep out of reach of children
- 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
Ask a doctor or pharmacist before use
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
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. - Stop use and ask a doctor if
- If pregnant or breast-feeding
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Product Label Tukol 504 DPL
Tukol®
DO NOT USE IF PRINTED SEAL UNDER CAP
IS TORN OR MISSING
Dextromethorphan HBr / Guaifenesin / Phenylephrine HCL
Expectorant/Cough Suppressant/Nasal Decongestant
Tukol®
Cough & Congestion
- Quiets Cough
- Thins and loosens phlegm
- Clears Nasal Congestion
Ages/ 12+ 4 FL OZ (118 mL)
2000005853
6 50066 00012 6
LOT No.
Exp.Distributed by
Genomma Lab USA Inc.Houston, TX 77027
BX-006 Rev. 03
Genoma Lab.®
rege
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INGREDIENTS AND APPEARANCE
TUKOL MULTI SYMPTOM COLD
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50066-504 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 RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL (UNII: L7T10EIP3A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50066-504-24 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/15/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/15/2012 Labeler - Genomma Lab USA, Inc. (832323534) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(50066-504)