Stona For Children Syrup
FDA Label NDC 49873-108

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sato Pharmaceutical Co., Ltd. for the product Stona For Children (NDC 49873-108). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

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

Otc - Purpose

Purpose
Acetaminophen    Pain reliever-fever reducer
Chlorpheniramine maleate    Antihistamine
Dextromethorphan hydrobromide    Cough suppressant

Indications & 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

Warnings

​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

Otc - 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 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.

Otc - Ask Doctor

Ask a doctor before use if the child has

  • a breathing problem such as chronic bronchitis
  • glaucoma
  • liver disease

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if the child is

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Otc - When Using

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

Otc - Stop Use

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.

Otc - Keep Out Of Reach Of Children

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.

Dosage & 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

Other Safety Information

​Other information

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

Inactive Ingredient

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.

Otc - Questions

​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

Package Label.Principal Display Panel

Pdp (Stsyrchildv2 Pdp)

Pdp (Stsyrchildv2 Pdp)

Image Description (Stsyrchildv2 Cart)

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