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NDC 52083-0628-16 PECGEN PSE Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor 10; 187; 30 mg/5mL; mg/5mL; mg/5mL Details
PECGEN PSE Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor 10; 187; 30 mg/5mL; mg/5mL; mg/5mL
PECGEN PSE Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Kramer Novis. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 52083-0628-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
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: 52083-0628-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.
Related Packages: 52083-0628-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
| NDC | 52083-0628 |
|---|---|
| Product ID | 52083-628_a70acfaf-c6eb-4994-9cc9-e1b1a99409dc |
| Associated GPIs | 43997303320949 |
| GCN Sequence Number | 071244 |
| GCN Sequence Number Description | guaifenesin/DM/pseudoephedrine LIQUID 187-10-30 ORAL |
| HIC3 | B4R |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT |
| GCN | 34975 |
| HICL Sequence Number | 000222 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR/PSEUDOEPHEDRINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | PECGEN PSE Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 10; 187; 30 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Labeler Name | Kramer Novis |
| Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 52083-0628-16 (52083062816)
| NDC Package Code | 52083-628-16 |
|---|---|
| Billing NDC | 52083062816 |
| Package | 474 mL in 1 BOTTLE (52083-628-16) |
| Marketing Start Date | 2014-08-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 5682ac21-f20e-453d-a8ba-f6ad7e4f1426 Details
Active Ingredients (in each 5 mL tsp)
Uses
Warnings
Do not use if you are 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlarged prostate gland • cough that occurs with too much phlegm (mucus) • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
When using this product do not use more than directed.
Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • 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.
If pregnant or breast-feeding, ask a health professional before use.
Directions
do not take more than 4 doses in any 24-hour period
| Adults and children 12 years of age and older |
2 teaspoonfuls (10 mL) every 4 hours, not to exceed 8 teaspoonfuls in 24 hours or as directed by a doctor |
| Children 6 to under 12 years of age |
1 teaspoonful (5 mL) every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by a doctor |
| Children 2 to under 6 years of age |
Consult a doctor |
Other information
Inactive ingredients
SPL UNCLASSIFIED SECTION
Contains the same active ingredients as Trispec® PSE
• SUGAR FREE • ALCOHOL FREE
• DYE FREE • GLUTEN FREE
GRAPE FLAVOR
Manufactured in the USA for Kramer Novis. San Juan, PR 00917.
Tel: (787) 767-2072 www.kramernovis.com
* Trispec® PSE is a Registered Trademark of Deliz Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Deliz Pharmaceutical Corp.
INGREDIENTS AND APPEARANCE
| PECGEN PSE COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR
dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride liquid |
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| Labeler - Kramer Novis (090158395) |
| Registrant - Kramer Novis (090158395) |