FDA Label for Supress-pe Pediatric
View Indications, Usage & Precautions
Supress-pe Pediatric Product Label
The following document was submitted to the FDA by the labeler of this product Kramer Novis. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredients (in each 1 mL) Purpose
Guaifenesin, 50 mg..............................................Expectorant
Phenylephrine HCl, 2.5 mg................................Nasal decongestant
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.