CHILDRENS TUKOL MULTI-SYMPTOM COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

Childrens Tukol Multi-Symptom Cold and Flu by

Drug Labeling and Warnings

Childrens Tukol Multi-Symptom Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA, Inc., Pharmalab Enterprises, Inc., AptaPharma Inc., Rnv LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug FactsActive 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:

• nasal congestion
• cough
• minor aches and pains
• sore throat
• headache
• temporarily reduces fever
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

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

• more tha 5 doses in 24 hours which is the maxium daily amount
• with other drugs containing acetaminophen

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 more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomitting, consult a doctor promptly.

Do not use

• with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug containd acetaminophen, ask a doctor or pharmacist
• for a child who is 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 an MAOI drug. If you do not know if ask a doctor or pharmacist beforre giving this product.

Ask a doctor before use if the child has

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• persistant or chronic cough such as occurs with asthma
• cough that occurs with too much phlegm (musus)

Ask a doctor or pharmacist before use if the child is

taking the blood thinning drug warfarin.

When using this product

• do not exceed recommended dose ( see overdose section).

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur
• redness or swelling is present
• pain, nasal congestion or cough gets worse or lasts more than 5 days
• new symptoms
• fever gets worse or lasts more than 3 days
• cough comes back, or occurs with rash or headache that lasts

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

• do not give more than directed
  (see Overdose warning)
• product not labeled with directions for adult use
• do not give more than 5 doses in any 24-hour period
• do not give for more than 5 days unless directed by a doctor
• measure only with dosing cup provided
• dose as follows or as directed by a doctor
• mL = milliliter; tsp - teaspoonful

Age                                                                    dose

Children 6 to under 12 years of age                     10 mL or 2 tsp every 4 hours

Children under 6 years of age                               do not use

Other information

• each 10 mL contains: sodium 6 mg
• store between 20-25°C (68-77°F)
• do not refrigerate
• dosing cup provided
• keep carton for complete Drug facts

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 1-877-99-GENOMA (43666)

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

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

Children's Tukol®

Acetaminophen/Guaifenesin/Dextromethorphan HBr/Phenylephrine HCL
Pain Reliever/Fever Reducer/Expectorant/Cough Suppressant/Nasal Congestion

NEW!

Multi-Symptom Cold & Flu

Ages 6-11

FeverSore Throat
Stuffy Nose
CoughPhlegm

BERRY flavor

4 FL OZ  (118 mL)

Distributed By
Genomma Lab USA Inc. Houston, TX 77027

BX-057

Lot:

Exp:

INGREDIENTS AND APPEARANCE

CHILDRENS TUKOL MULTI-SYMPTOM COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-519
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-519-24	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/04/2016

Labeler - Genomma Lab USA, Inc. (832323534)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(50066-519)