SUPRESS A- dexbromopheniramine maleate, dextromethorphan hbr, phenylephrine hcl 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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SUPRESS A

Active ingredients (in each 1 mL)

Dexbrompheniramine Maleate, 1 mg

Dextromethorphan HBr, 10 mg

Phenylephiren HCl, 5 mg

Purpose

Antihistamine

Cough suppressant

Expectorant

Uses

Warnings

Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

When using this product

Stop use and ask a doctor if

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

Children 6 to under 12 years of age

Other information

Inactive ingredients

Citric acid, flavor, glycerin, methylparaben, polysorbate, propylene glycol, propyl paraben, purified water, sodium citrate and sucralose.

Made in the USA for Kramer Novis.

San Juan, PR 00917

(787) 767-2072 / www.kramernovis.com

PRINCIPAL DISPLAY PANEL

image description

SUPRESS A 
dexbromopheniramine maleate, dextromethorphan hbr, phenylephrine hcl syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-057
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE1 mg  in 1 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (GRAPE) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52083-057-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/01/2012
Labeler - Kramer Novis (090158395)
Registrant - KRAMER NOVIS (090158395)

Revised: 12/2017
Document Id: f3752319-1292-4d33-8d94-37b5a295b265
Set id: f0bec5f5-4d76-471e-9024-557eba848b93
Version: 2
Effective Time: 20171222
 
Kramer Novis