Otc - Active Ingredient
Active Ingredients (in each 1 mL) Purpose
Guaifenesin, 50 mg..............................................Expectorant
Phenylephrine HCl, 2.5 mg................................Nasal decongestant
Supress-pe Solution/ Drops
FDA Label NDC 52083-056
Full FDA labeling including 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-pe (NDC 52083-056). 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, warnings, otc - do not use, otc - keep out of reach of children, dosage & administration, indications & usage, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- temporarily relieves nasal congestion due to the common cold
Warnings
Warnings
Do not use
in 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 a MAOI, ask a doctor or pharmacist before giving this product.
Otc - Do Not Use
Ask a doctor before use if your child has
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- a cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with asthma
- your child gets nervous, dizzy or sleepless
- symptoms do not get better within 7 days or are accompanied by fever
- cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be a signs of a serious condition.
When using this product do not exceed recommended dosage
Stop use and ask a doctor if
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
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
| Age | Dose |
| children 2 to under 6 years of age | 1 mL |
| children under 2 years of age | ask physician |
Indications & Usage
Other information
Tamper Evident Feature: Do not use if cap seal is torn, broken or missing. For your protection, this bottle has an imprinted seal around the neck.
Store at controlled room temperature 15-30°C (59-86°F).
Avoid excessive heat and humidity.
Inactive Ingredient
Inactive ingredients Citric acid, glycerin, grape flavor, methylparaben, polyethylene glycol, purified water, propylene glycol, propylparaben, sodium citrate, sucralose and sucrose.
Otc - Questions
Manufacture in the USA for Kramer-Novis, San Juan, PR 00917. Tel: (787) 767-2072
Pricipal Display Panel
SUPRESS-PE
PEDIATRIC DROPS
EXPECTORANT
NASAL-DECONGESTANT
Great Grape Flavor
DYE FREE
ALCOHOL FREE
SACCHARINE FREE
NET CONTENT: 30 mL (1 Fl. Oz.)
MANUFACTURED IN USA FOR
KRAMER-NOVIS
San Juan, P.R. 00917
* Please review the disclaimer below.
