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TUSSI PRES PEDIATRIC

Medically reviewed on March 26, 2018

Dosage form: syrup
Ingredients: GUAIFENESIN 75mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 5mL, DEXTROMETHORPHAN HYDROBROMIDE 5mg in 5mL
Labeler: KRAMER NOVIS
NDC Code: 52083-232

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.

Drug Facts

Active Ingredients (per 5 ml): Guaifenesin........75 mg

                                           Phenylephrine HCl 2.5 mg

                                           Dextromethorphan HBr 5 mg

Purpose:Expectorant, Decongestant, Antitussive (Anti Cough)

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.

If you have: 

heart disease

thyroid disease

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

Adults and Children 12 years and over-20 ml(4 tsp) every 4 hours

Children 6 years to under 12 years-10ml (2 tsp) every 4 hours

Children 2 years to under 6 years-5ml (1 tsp) every 4 hours

under 2 years-Do not use

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

keep out of reach of children

Inactive Ingredients: Citric Acid, Glycerin,Methylparaben,Natural Flavor,Propylene Glycol,Propylparaben,Purified Water,Sodium Citrate and Sucralose

MM1

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

TUSSI PRES PEDIATRIC 
guaifenesin, phenylephrine hcl,dextromethorphan hydrobromide syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-232(NDC:62959-103)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN75 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CITRIC ACID MONOHYDRATE 
GLYCERIN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SODIUM CITRATE 
METHYLPARABEN 
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGE (CITRUS ORANGE) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:52083-232-0130 mL in 1 BOTTLE
2NDC:52083-232-04120 mL in 1 BOTTLE
3NDC:52083-232-16480 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/24/2011
Labeler - KRAMER NOVIS (090158395)
Registrant - KRAMER NOVIS (090158395)
Establishment
NameAddressID/FEIOperations
ULTRATAB LABORATORIES151051757manufacture
Establishment
NameAddressID/FEIOperations
ULTRASEAL CORPORATION085752004repack

 
KRAMER NOVIS

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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