TUKOL MAX ACTION COLD SORE THROAT AND COUGH- acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride solution

TUKOL MAX ACTION COLD SORE THROAT AND COUGH by

Drug Labeling and Warnings

TUKOL MAX ACTION COLD SORE THROAT AND COUGH by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA Inc, Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each 20 mL)

Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg

Purposes

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 contains acetaminophen. Severe liver damage may occur if you take:

• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening, blisters and 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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist

• if you are 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

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• a breathing problem such as chronic bronchitis
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
•  cough that occurs with too much phlegm (mucus)
• trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if

you are taking the blood thinning drug warfarin

When using this product

do not use more than directed

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• pain, nasal congestion or cough gets worse or lasts more than 7 days
• cough comes back or occurs with fever, rash, or headache that lasts
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur.

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.

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

• Do not take more than directed
• Do not take more than 6 doses in 24 hours
• This adult strength product is not intended for use in children under 12 years of age
• Dose as follows or as directed by a doctor
• Use dose cup provided

• age: dose
• adults and children 12 years and older: 20 mL every 4 hours
• children under 12 years of age: do not use

Other information

• Each 20 mL contains: sodium 12 mg
• Store at 20-25°C (68-77°F), do not refrigerate

Inactive ingredients

Citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions or comments?

1 877 99 GENOM (43666) Monday to Friday from 8 AM to 6 PM, Central time. 

Distributed by:
Genomma Lab USA Inc.,
Houston, TX 77027

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)

MAX STRENGTH

ACETAMINOPHEN / Guaifenesin / Phenylephrine HCI / Dextromethorphan HBr

Tukol®

MAX ACTION

COLD, SORE THROAT & COUGH

• Fever & Headache
• Clears Nasal Congestion
• Thins & Loosens Mucus
• Controls Cough 

Ages 12+     6 FL OZ (177 ml)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle) - Carton

MAX STRENGTH

ACETAMINOPHEN / Guaifenesin / Phenylephrine HCI / Dextromethorphan HBr

Tukol®

MAX ACTION

COLD, SORE THROAT & COUGH

• Fever & Headache
• Clears Nasal Congestion
• Thins & Loosens Mucus
• Controls Cough

Ages 12+     6 FL OZ (177 ml)

INGREDIENTS AND APPEARANCE

TUKOL MAX ACTION COLD SORE THROAT AND COUGH 
acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-916
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 20 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)
PINEAPPLE (UNII: 2A88ZO081O)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYL GALLATE (UNII: 8D4SNN7V92)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	BLUE (Blue to Bluish Green)	Score
Shape		Size
Flavor	BERRY, PINEAPPLE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-916-18	1 in 1 CARTON	11/15/2017
1		177 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	11/15/2017

Labeler - Genomma Lab USA Inc (832323534)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(50066-916)