SUPRESS DM- dextromethorphan hydrobromide, guaifenesin 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 DM

Drug Facts

Active Ingredients (in each 1 ml)

Dextromethorphan HBr, 5 mg

Guaifenesin, 50 mg

Purpose

Cough Suppressant

Expectorant

Uses

• Temporarily controls cough due to minor throat and bronchial irritation as may occur with a cold
• Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive.

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 your child has

When using this product do not exceed the recommended dosage.

Stop use and ask a doctor if

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

• 1 mL every 4 hours as needed, do not exceed 6 doses in any 24-hour, or as directed by a doctor

• Children under 6, consult a doctor

Inactive ingredients

Citric acid, flavor, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate and sodium saccharin.

Other information

• Tamper Evident Feature: Do not use if cap seal is torn, broken or missing.

• Store at controlled room temperature 15°-30°C (59°-86°F).

• Avoid excessive heat and humidity.

COUGH SUPRESSANT

EXPECTORANT

No sugar, dye, alcohol, aspartame or sorbitol

DECONGESTANT FREE

Manufacture in the USA for Kramer-Novis, San Juan, PR 00917. Tel: (787) 767-2072

www.kramernovis.com

Packaging

image description

SUPRESS DM 
dextromethorphan hydrobromide, guaifenesin syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-058
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN50 mg  in 1 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (SWEET CHERRY) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52083-058-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product10/02/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/02/2013
Labeler - KRAMER NOVIS (090158395)
Registrant - KRAMER NOVIS (090158395)

Revised: 11/2018
Document Id: 584d5e8d-618d-4451-9c23-897f64b3e34c
Set id: 7da0611e-729c-4cf8-88f3-f8877b9f5cfa
Version: 4
Effective Time: 20181123
 
KRAMER NOVIS