DRUG FACTS

Drug Labeling and Warnings

Drug Details [pdf]

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.

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DRUG FACTS

Active Ingredients per 5 ml: Guaifenesin 200 mg, Phenylephrine HCL 5 mg, Dextromethorphan HBr 10 mg

COUGH SUPPRESSANT

NASAL DECONGESTANT

EXPECTORANT

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

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, thyroid disease, high blood pressure, diabetes

trouble urinating due to enlargement of the prostate gland

cough that occurs with too much phlegm (mucus)

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

adults and children 12 years and over 10mL (2 tsp) every 4 hours

children 6 to under 12 years 5mL (1 tsp) every 4 hours

children 2 to under 6 years 2.5mL (1/2 tsp) every 4 hours

under 2 years do not use

do not take more than 6 doses in any 4 hour period

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

Keep out of reach of children

Inactive Ingredients:

citric acid,red 40,glycerin,methylparaben,potassium sorbate,propylene glycol,propylparaben,purified water,sodium citrate,sucralose

TUSSI PRES 
guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52083-233
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52083-233-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/28/2011
2	NDC: 52083-233-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/28/2011
3	NDC: 52083-233-16	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/28/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/28/2011	10/30/2019

Labeler - Kramer Novis (090158395)

Registrant - Kramer Novis (090158395)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		085752004	repack(52083-233)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab Laboratories, Inc.		151051757	manufacture(52083-233)

Revised: 10/2019

Document Id: 96266078-caf2-0dd1-e053-2a95a90a9593

34390-5

Set id: ae22de1e-1faa-4c2e-92a1-02d03e2faa40

Version: 4

Effective Time: 20191030

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