Supress DX Pediatric Drops

Dosage form: syrup
Ingredients: GUAIFENESIN 50mg in 1mL, DEXTROMETHORPHAN HYDROBROMIDE 5mg in 1mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 1mL
Labeler: KRAMER NOVIS
NDC Code: 52083-055

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

Actives per ml: Guaifenesin 50 mg, Dextromethorphan Hydrobromide 5 mg, Phenylephrine Hydrochloride 2.5 mg

Expectorant, antitussive (anti cough), nasal decongestant

temporarily: relieves nasal congestion associated with sinusitis , relieves nasal congestion due to the common

cold, hay fever or other upper respiratory allergies ,relieves sinus congestion and pressure ,helps decongest sinus openings
and passages, helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome
 
mucus,drain bronchial tubes, and make coughs more productive, restores free breathing, suppresses cough due to minor
throat and bronchial irritation associated with a cold or inhaled irritants

Children 2-6 years, Take 1 ml every 4 hours as needed, do not exceed 8 ml in 24 hours, or as directed by a doctor.Children under 2 years, consult a physician

WarningsA persistent cough may be a sign of a serious condition.  If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor

Do not: Use more than the recommended dose.Do not give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor.Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland
Do not take this product 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 MAOI drug
If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product
Stop use and ask a doctor if: symptoms do not improve, new symptoms occur, redness or swelling is present, nervousness, dizziness or sleeplessness occur, symptoms do not improve within 7 days or are accompanied by fever, cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache
Ask a doctor before use if you have: heart diseasem, high blood pressure, thyroid disease, diabetes, difficulty in urination due to enlargement of the prostate gland, persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)

As with any drug, if you are pregnant or nursiong a baby, consult a health professional before using this product

Keep this and all medicines out of the reach of children

Inactive Ingredients: Citric Acid, Flavor, Glycerin, Red 40, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate, Sodium Saccharin,

MM1

SUPRESS DX PEDIATRIC DROPS 
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-055(NDC:62959-102)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN50 mg  in 1 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CITRIC ACID MONOHYDRATE 
GLYCERIN 
SODIUM CITRATE 
METHYLPARABEN 
PROPYLPARABEN 
PROPYLENE GLYCOL 
SACCHARIN SODIUM 
FD&C RED NO. 40 
Product Characteristics
Colorred (CHERRY RED) Score    
ShapeSize
FlavorCHERRY (SOUR CHERRY) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:52083-055-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/29/2011
Labeler - KRAMER NOVIS (090158395)
Registrant - KRAMER NOVIS (090158395)
Establishment
NameAddressID/FEIOperations
ULTRAtab Laboratories, Inc.151051757manufacture
Establishment
NameAddressID/FEIOperations
Ultra Seal Corporation085752004repack

Revised: 03/2011
 
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.

Hide
(web1)