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NDC 52083-0231-16 Tussi Pres 10; 200; 5 mg/5mL; mg/5mL; mg/5mL Details

Tussi Pres 10; 200; 5 mg/5mL; mg/5mL; mg/5mL

Tussi Pres is a ORAL SYRUP in the HUMAN OTC DRUG category. It is labeled and distributed by Kramer Novis. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE 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: 52083-0231-16
Last 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: 52083-0231-16
Last 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: 52083-0231-16
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	52083-0231
Product ID	52083-231_40bc9e45-285b-479b-b160-8cee2cf8ba40
Associated GPIs	43997303100970
GCN Sequence Number	065638
GCN Sequence Number Description	guaifen/dextromethorphan/PE LIQUID 200-10-5/5 ORAL
HIC3	B4R
HIC3 Description	NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT
GCN	27655
HICL Sequence Number	000216
HICL Sequence Number Description	GUAIFENESIN/DEXTROMETHORPHAN HBR/PHENYLEPHRINE
Brand/Generic	Generic
Proprietary Name	Tussi Pres
Proprietary Name Suffix	n/a
Non-Proprietary Name	guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide
Product Type	HUMAN OTC DRUG
Dosage Form	SYRUP
Route	ORAL
Active Ingredient Strength	10; 200; 5
Active Ingredient Units	mg/5mL; mg/5mL; mg/5mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	Kramer Novis
Pharmaceutical Class	Adrenergic alpha1-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	2024-12-31

Package

Package Images

NDC 52083-0231-16 (52083023116)

Pricing Information	N/A
NDC Package Code	52083-231-16
Billing NDC	52083023116
Package	480 mL in 1 BOTTLE (52083-231-16)
Marketing Start Date	2011-03-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0d4ee530-2a5c-41a0-88bf-ac92d538661b Details

Drug Facts

Active Ingredients (in each 5mL tsp)

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purposes

Cough suppressant

Expectorant

Nasal decongestant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
temporarily relieves these symptoms occurring with cold:
- nasal congestion
- cough due to minor throat and bronchial irritation

Warnings

Do not use:

in a child under 2 years of age
if you are 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

• trouble urinating due to an enlarged prostate gland

• cough that occurs with too much phlegm (mucus)

• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

When using this product do not exceed recommended dosage.

Stop use and ask a doctor if

• you get 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.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

do not take more than 6 doses in any 24-hour period


EVERY 4 HOURS	ADULTS AND CHILDREN 12 YEARS AND OVER	10 mL (2 tsp)
	CHILDREN 6 YEARS TO UNDER 12 YEARS	5 mL (1 tsp)
	CHILDREN 2 YEARS TO UNDER 6 YEARS	2.5 mL (1/2 tsp)
	CHILDREN UNDER 2 YEARS OF AGE	do not use

Other information

Tamper evident feature. Do not use if inner 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, and sucralose.

SPL UNCLASSIFIED SECTION

Dextromethorphan HBr

COUGH SUPPRESSANT

Guaifenesin

EXPECTORANT

Phenylephrine HCl

NASAL DECONGESTANT

SUGAR, ALCOHOL, SACCHARIN & SORBITOL FREE

CHERRY FLAVOR

Manufactured in the USA for Kramer-Novis, San Juan, PR 00917

Tel: (787) 767-2072 www.kramernovis.com

Packaging

INGREDIENTS AND APPEARANCE

TUSSI PRES

guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52083-231
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	red (CHERRY RED)	Score
Shape		Size
Flavor	CHERRY (SOUR CHERRY)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52083-231-16	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/28/2011
2	NDC:52083-231-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/28/2011	07/12/2017
3	NDC:52083-231-10	10 mL in 1 PACKET; Type 0: Not a Combination Product	03/28/2011	10/31/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/28/2011

Labeler - Kramer Novis (090158395)

Registrant - Kramer Novis (090158395)

Revised: 10/2022

Document Id: 40bc9e45-285b-479b-b160-8cee2cf8ba40

Set id: 0d4ee530-2a5c-41a0-88bf-ac92d538661b

Version: 4

Effective Time: 20221031