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

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg 

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant 


Medication Information

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

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg 

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

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.

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
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.
Questions?

1-855-470-6722

Other Information

Keep out of reach of children.

Active Ingredients

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg 

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

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

Uses
  • temporarily relieves common cold/flu symptoms:
    • nasal congestion
    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches & pains
    • fever
Dosage and Administration (34068-7)

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

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

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant 

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.

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
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.
Questions?

1-855-470-6722

Other Information

Keep out of reach of children.

Active Ingredients (Active ingredients)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg 

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

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. 


Advanced Ingredient Data


Raw Label Data

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