Supress Dx Pediatric Drops Syrup
FDA Label NDC 52083-055
12 label sections · Submitted to the FDA by Kramer Novis · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kramer Novis for the product Supress Dx Pediatric Drops (NDC 52083-055). 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 drug facts, active ingredients (in each 1 ml), purposes, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each 1 Ml)
Dextromethorphan HBr, 5 mg
Guaifenesin, 50 mg
Phenylephrine HCl, 2.5 mg
Purposes
Cough Suppressant
Expectorant
Nasal Decongestant
Uses
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
• temporarily relieves:
• nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis)
• cough due to minor throat and bronchial irritation as may occur with the common cold
Warnings
Do not use in a child who is 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.
Ask a doctor before use if the child has
• heart disease • thyroid disease • high blood pressure • diabetes • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with asthma.
When using this product, do not use more than directed.
Stop use and ask a doctor if
• your child gets nervous, dizzy, or sleepless
• symptoms do not get better within 7 days or are accompanied by fever
• cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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.
Directions
• do not use more than 6 doses in any 24-hour period
• repeat every 4 hours
• measure with the dosage device provided. Do not use with any other device
• mL = milliliter
• Children 2 to under 6 years of age: 1 mL
• Children under 2 years of age: do not use.
Other Information
• Tamper Evident Feature: Do not use if printed seal is torn, broken or missing
• Store at controlled room temperature 15-30°C (59-86°F)
• Avoid excessive heat and humidity.
Inactive Ingredients
citric acid, FD&C Red 40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, sucralose
Questions Or Comments?
1-787-767-2072 You may also report serious side effects to this phone number.
Call weekdays from 8AM to 4PM AST.
Recent Major Changes
Directions: (The following changes were made)
- mL=milliliter
- Children under 2 years of age: do not use.
Unclassified section (The following information has been included)
• For relief of:
+ Cough
+ Chest Congestion/Mucus
+ Stuffy Nose
Packaging
Supress Dx Pediatric Drops (52083055 2)
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