TUKOL NIGHT TIME COLD AND FLU RELIEF SOFTGELS- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled 
Genomma Lab USA

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.

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Tukol® Night Time Cold and Flu Relief Softgels

Drug Facts

Active ingredients (in each softgel)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 15 mgCough suppressant
Doxylamine succinate 6.25 mgAntihistamine

Uses

temporarily relieves common cold and flu symptoms:

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash If skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

  • with any other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • 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 drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • to make a child sleep

Ask a doctor before use if you have

  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drink
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or last more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts
  • a skin reaction occurs. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Directions

Other information

Inactive Ingredients

FD&C Blue #1, D&C Yellow #10, Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol, Purified water, Sorbitol sorbitan solution, Titanium dioxide.

Questions or comments?

Call toll free 1-877-994-3666

Weekdays from 8 am to 6 pm

Distributed by
Genomma Lab USA, Inc.
Houston, TX 77098

PRINCIPAL DISPLAY PANEL - 24 Softgel Blister Pack Carton

NEW

Tukol®

NIGHT TIME
COLD AND FLU RELIEF

Acetaminophen / Dextromethorphan HBr /
Doxylamine succinate

COUGH
RUNNY NOSE
SORE THROAT
ACHES
NASAL CONGESTION
FEVER

24
Softgels

PRINCIPAL DISPLAY PANEL - 24 Softgel Blister Pack Carton
TUKOL NIGHT TIME COLD AND FLU RELIEF SOFTGELS 
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-311
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide15 mg
Doxylamine succinate (UNII: V9BI9B5YI2) (Doxylamine - UNII:95QB77JKPL) Doxylamine succinate6.25 mg
Inactive Ingredients
Ingredient NameStrength
gelatin, unspecified (UNII: 2G86QN327L)  
glycerin (UNII: PDC6A3C0OX)  
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
povidone, unspecified (UNII: FZ989GH94E)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize11mm
FlavorImprint Code 603
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-311-242 in 1 CARTON01/10/2023
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/10/2023
Labeler - Genomma Lab USA (832323534)

Revised: 1/2023
Document Id: 2de4de60-b5c8-4933-9dab-e47321b8f799
Set id: 57ab72e4-75f9-4044-bdc7-d515fdcc0116
Version: 1
Effective Time: 20230110
 
Genomma Lab USA