TUSSI PRES- guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide syrup 
Kramer Novis

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

TUSSI-PRES

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

Warnings

Do not use:

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

Inactive ingredients

Citric acid, FD&C Red 40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose.

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

Tusi10

Tusi16

TUSSI PRES 
guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-231
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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
Colorred (CHERRY RED) Score    
ShapeSize
FlavorCHERRY (SOUR CHERRY) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52083-231-16480 mL in 1 BOTTLE; Type 0: Not a Combination Product03/28/2011
2NDC:52083-231-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/28/201107/12/2017
3NDC:52083-231-1010 mL in 1 PACKET; Type 0: Not a Combination Product03/28/201110/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/28/2011
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
 
Kramer Novis