Stona Syrup For Children (pld/mfr)

Stona Syrup For Children (pld/mfr)
SPL v6
SPL
SPL Set ID 18f3d694-9dff-407e-a264-916dbd201f9a
Route
ORAL
Published
Effective Date 2017-03-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Chlorpheniramine (2 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Butylparaben Alcohol Citric Acid Monohydrate Fd&c Red No. 40 Propylparaben Propylene Glycol Sodium Benzoate Sodium Hydroxide Saccharin Sodium Sucrose Water Polyethylene Glycol 1500

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2001-01-03

Description

Active ingredients (in 15 mL) Acetaminophen 325mg Chlorpheniramine maleate 2mg Dextromethorphan hydrobromide 10mg


Medication Information

Warnings and Precautions

​Warnings

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

  • more than 5 doses in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
Indications and Usage

Uses

  • For the temporary relief of the following cold symptoms 
  • minor aches and pains
  • headache
  • sneezing
  • runny nose
  • cough due to minor throat and bronchial irritation
  • temporarily reduces fever
Dosage and Administration

Directions

  • do not take more than 5 doses in any 24 hour period
  • use only with enclosed measuring cup
  • dose as follows while symptoms persist, or as directed by a doctor

      children 6 to under 12 years of age: Take 15 mL every 4 hours

      children under 6 years of age: do not use. ask a doctor.

​This product does not contain directions or complete warnings for adult use

Description

Active ingredients (in 15 mL) Acetaminophen 325mg Chlorpheniramine maleate 2mg Dextromethorphan hydrobromide 10mg

Section 50565-1

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Section 50566-9

Stop use and ask a doctor if

■pain or cough gets worse or lasts more than 5 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.

Section 50567-7

When using this product

  • do not exceed recommended dosage
  • may cause excitability in children
  • may cause marked drowsiness
  • sedatives and tranquilizers may increase the drowsiness effect
Section 50568-5

Ask a doctor or pharmacist before use if the child is

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
Section 50569-3

Ask a doctor before use if the child has

  • a breathing problem such as chronic bronchitis
  • glaucoma
  • liver disease
Section 50570-1

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 your child is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Section 51727-6

Inactive ingredients

alcohol, butylparaben, citric acid, FD&C Red No. 40, flavor, polyethylene glycol 1540, propylparaben, propylene glycol, saccharin sodium, sodium benzoate, sodium hydroxide, sucrose, water.

Section 53413-1

​Questions or comments?

or to report serious adverse events associated with the use of this product call weekdays, 9 am - 5 pm at 1-310-787-1877 or write to the address on the front panel

Section 55105-1

Purpose

Acetaminophen    Pain reliever-fever reducer

Chlorpheniramine maleate    Antihistamine

Dextromethorphan hydrobromide    Cough suppressant

Section 55106-9

Active ingredients (in 15 mL)

Acetaminophen 325mg

Chlorpheniramine maleate 2mg

Dextromethorphan hydrobromide 10mg

Section 60561-8

​Other information

  • ​keep container tightly closed
  • store at room temperature (20​​-25 C or 68-77 F)
Carton Image


Structured Label Content

Indications and Usage (34067-9)

Uses

  • For the temporary relief of the following cold symptoms 
  • minor aches and pains
  • headache
  • sneezing
  • runny nose
  • cough due to minor throat and bronchial irritation
  • temporarily reduces fever
Dosage and Administration (34068-7)

Directions

  • do not take more than 5 doses in any 24 hour period
  • use only with enclosed measuring cup
  • dose as follows while symptoms persist, or as directed by a doctor

      children 6 to under 12 years of age: Take 15 mL every 4 hours

      children under 6 years of age: do not use. ask a doctor.

​This product does not contain directions or complete warnings for adult use

Warnings and Precautions (34071-1)

​Warnings

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

  • more than 5 doses in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
Section 50565-1 (50565-1)

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

■pain or cough gets worse or lasts more than 5 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.

Section 50567-7 (50567-7)

When using this product

  • do not exceed recommended dosage
  • may cause excitability in children
  • may cause marked drowsiness
  • sedatives and tranquilizers may increase the drowsiness effect
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the child is

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
Section 50569-3 (50569-3)

Ask a doctor before use if the child has

  • a breathing problem such as chronic bronchitis
  • glaucoma
  • liver disease
Section 50570-1 (50570-1)

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 your child is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Section 51727-6 (51727-6)

Inactive ingredients

alcohol, butylparaben, citric acid, FD&C Red No. 40, flavor, polyethylene glycol 1540, propylparaben, propylene glycol, saccharin sodium, sodium benzoate, sodium hydroxide, sucrose, water.

Section 53413-1 (53413-1)

​Questions or comments?

or to report serious adverse events associated with the use of this product call weekdays, 9 am - 5 pm at 1-310-787-1877 or write to the address on the front panel

Section 55105-1 (55105-1)

Purpose

Acetaminophen    Pain reliever-fever reducer

Chlorpheniramine maleate    Antihistamine

Dextromethorphan hydrobromide    Cough suppressant

Section 55106-9 (55106-9)

Active ingredients (in 15 mL)

Acetaminophen 325mg

Chlorpheniramine maleate 2mg

Dextromethorphan hydrobromide 10mg

Section 60561-8 (60561-8)

​Other information

  • ​keep container tightly closed
  • store at room temperature (20​​-25 C or 68-77 F)
Carton Image


Advanced Ingredient Data


Raw Label Data

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