Label: TUKOL MAXIUM STRENGTH COUGH AND MUCUS RELIEF- dextromethorphan hydrobromide, guaifenesin capsule, gelatin coated
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Contains inactivated NDC Code(s)
NDC Code(s): 50066-601-02 - 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 March 11, 2015
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- Official Label (Printer Friendly)
- Drug Facts Active ingredients
- Purpose
- Keep out of reach of children
- Uses
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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
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Tukol Maximum Strength Cough and Mucus Relief Label
Tukol®
Dextromethorphan HBr-Cough suppressant / Guaifensin-Expectorant
Relieves
Cough
MucusUse 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 77027BX - 048
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INGREDIENTS AND APPEARANCE
TUKOL MAXIUM STRENGTH COUGH AND MUCUS RELIEF
dextromethorphan hydrobromide, guaifenesin capsule, gelatin coatedProduct 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)