CHILDRENS TUKOL MULTI-SYMPTOM COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid 
Genomma Lab USA, Inc.

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Children's Tukol Multi-Symptom Cold & Flu   519

Drug Facts
Active ingredients
(in each 10 mL = 2 teaspoonful)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCL 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses

temporarily relieves these common cold and flu symptoms:

Warnings

Liver warning: This product cantains acetaminophen. Severe liver damage may occur if your child takes

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomitting, consult a doctor promptly.

Do not use

Ask a doctor before use if the child has

Ask a doctor or pharmacist before use if the child is

taking the blood thinning drug warfarin.

When using this product

Stop use and ask a doctor if

These could be signs of a serious condition.

Keep out of reach of children.

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Quick medical attentioni is critical even if you do not notice any signs or symptoms.

Directions

 agedose 
 children 6 to under 12 years of age2 teaspoons (10 mL) every 4 hours 
 children under 6 years of agedo not use 

Other information

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red # 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, orbitol, sucralsoe, xanthan gum

Questions?

Call 1-877-994-3666

Children's Tukol Multi-Symptom Cold & Flu product label

PLE Berry Kids

KEEP CARTON FOR COMPLETE DRUG FACTS

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Tukol®

Childrens

COLD & FLU

Acetaminophen 325 mg/Dextromethorphan HBr 10 mg/Guaifenesin 200 mg/Phenylephrine HCL 5 mg

Ages 6-11

Relieves

Minor Aches & Pain

Fever

Nasal & Chest Congestion

4 FL OZ  (118 mL)

Distributed By
Genomma Lab USA Inc. Houston, TX 77098

CHILDRENS TUKOL MULTI-SYMPTOM COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-519
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-519-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/04/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01205/04/2016
Labeler - Genomma Lab USA, Inc. (832323534)
Registrant - Genomma Lab USA, Inc. (832323534)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(50066-519)
Establishment
NameAddressID/FEIBusiness Operations
Rnv LLC118917568manufacture(50066-519)

Revised: 1/2024
Document Id: 4aa9c4b3-12e4-4e80-9765-be13234ba585
Set id: 85fe6f0f-41c8-44d3-a34a-355938da5f72
Version: 6
Effective Time: 20240111
 
Genomma Lab USA, Inc.