Tukol max action cold sore throat and cough solution

Drug facts

Active ingredients (in each20 mL)

Acetaminophen 650 mg
Dextromethorphan HBr20 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 Parkinsons 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 20-25C (68-77F), 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 8AM to 6PM, Central time.

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

Ingredients and appearance - Product information

Tukol max action cold sore throat and cough solution- Acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 50066-916
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 650 mgin 20 mL
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 20 mgin 20 mL
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 400 mgin 20 mL
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 10 mgin 20 mL

Inactive Ingredients

Ingredient Name Code
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) Flavor PINEAPPLE

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA

Labeler - Genomma Lab USA Inc( 832323534)

Establishment

Name ID/FEI Business Operations
Genomma Lab USA Inc 832323534 MANUFACTURE( 50066-916)

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

Ages12+ 6 FL OZ (177 ml)


Package label-principal display panel6 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)