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NDC 52083-0056-01 SUPRESS-PE 50; 2.5 mg/mL; mg/mL Details
SUPRESS-PE 50; 2.5 mg/mL; mg/mL
SUPRESS-PE is a ORAL SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Kramer Novis. The primary component is GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 52083-0056-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 52083-0056-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 52083-0056 |
|---|---|
| Product ID | 52083-056_6b4b229d-56e9-4920-9549-f60f50667f27 |
| Associated GPIs | 43996202100950 |
| GCN Sequence Number | 064525 |
| GCN Sequence Number Description | guaifenesin/phenylephrine HCl DROPS 50-2.5/ML ORAL |
| HIC3 | B4W |
| HIC3 Description | DECONGESTANT-EXPECTORANT COMBINATIONS |
| GCN | 14487 |
| HICL Sequence Number | 000250 |
| HICL Sequence Number Description | GUAIFENESIN/PHENYLEPHRINE HCL |
| Brand/Generic | Brand |
| Proprietary Name | SUPRESS-PE |
| Proprietary Name Suffix | Pediatric |
| Non-Proprietary Name | Guiafenesin, Phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION/ DROPS |
| Route | ORAL |
| Active Ingredient Strength | 50; 2.5 |
| Active Ingredient Units | mg/mL; mg/mL |
| Substance Name | GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Kramer Novis |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 52083-0056-01 (52083005601)
| NDC Package Code | 52083-056-01 |
|---|---|
| Billing NDC | 52083005601 |
| Package | 30 mL in 1 BOTTLE, DROPPER (52083-056-01) |
| Marketing Start Date | 2014-01-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL a474171d-5c29-4a80-9d37-00613796211a Details
Uses
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 a 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 EXCEED RECOMMENDED DOSAGE
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 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.
Directions
Other information
Inactive ingredients
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| SUPRESS-PE
PEDIATRIC
guiafenesin, phenylephrine hcl solution/ drops |
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| Labeler - Kramer Novis (090158395) |