tylo cold & flu (day)

tylo cold & flu (day)
SPL v1
SPL
SPL Set ID 7ba22bc1-6d5a-4e1e-87e3-c9f69fae0cb7
Route
oral
Published
Effective Date 2019-01-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (325 mg) dextromethorphan (10 mg) phenylephrine (5 mg)
Inactive Ingredients
fd&c red no. 40 fd&c yellow no. 6 gelatin glycerin polyethylene glycol, unspecified povidone propylene glycol water sorbitol titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: SN2;WHITE;INK Shape: oval Color: orange Size: 25 mm Score: 1
Marketing Status
otc monograph not final active Since 2019-01-17

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant 

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg 


Medication Information

Warnings

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

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

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.

Uses
  • temporarily relieves common cold/flu symptoms:
    • nasal congestion
    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches & pains
    • fever
Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant 

Dosage and Administration

when using other Tylo Cold & Flu Day or Night products, carefully read each label to ensure correct dosing

Directions
  • take only as directed - see Overdose warning
  • do not exceed 4 doses per 24 hrs 
  • adults & children 12 yrs & over: 2 Softgels with water every 4 hrs
  • children 4 to under 12 yrs: ask a doctor
  • children under 4 yrs: do not use
Other Information

Keep out of reach of children.

Inactive Ingredients

FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg 

Questions?

1-855-470-6722

Section 42229-5

Overdose warning Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Section 44425-7

Other information:

store at room temperature

Section 51945-4

TYLO COLD & FLU (Day)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

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 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 drug. If you do not know if your prescription drug contains MAOI, ask a doctor or pharmacist before taking this product.
Active Ingredients

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg 

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 get worse or last more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with rash or headache that lasts.

These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • cough that occurs with too much phlegm (mucus)
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema.
Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin. 


Structured Label Content

Warnings

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

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

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.

Uses
  • temporarily relieves common cold/flu symptoms:
    • nasal congestion
    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches & pains
    • fever
Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant 

Dosage and Administration (34068-7)

when using other Tylo Cold & Flu Day or Night products, carefully read each label to ensure correct dosing

Directions
  • take only as directed - see Overdose warning
  • do not exceed 4 doses per 24 hrs 
  • adults & children 12 yrs & over: 2 Softgels with water every 4 hrs
  • children 4 to under 12 yrs: ask a doctor
  • children under 4 yrs: do not use
Other Information

Keep out of reach of children.

Inactive Ingredients (Inactive ingredients)

FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions?

1-855-470-6722

Section 42229-5 (42229-5)

Overdose warning Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Section 44425-7 (44425-7)

Other information:

store at room temperature

Section 51945-4 (51945-4)

TYLO COLD & FLU (Day)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Do Not Use (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 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 drug. If you do not know if your prescription drug contains MAOI, ask a doctor or pharmacist before taking this product.
Active Ingredients (Active ingredients)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg 

When Using This Product (When using this product)

do not use more than directed.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you get nervous, dizzy or sleepless
  • pain, nasal congestion or cough get worse or last more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with rash or headache that lasts.

These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • cough that occurs with too much phlegm (mucus)
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema.
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin. 


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