SUPRESS DM- dextromethorphan hydrobromide, guaifenesin syrup

Supress DM by

Drug Labeling and Warnings

Supress DM by is a Otc medication manufactured, distributed, or labeled by KRAMER NOVIS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with asthma.

When using this product do not exceed the recommended dosage.

Stop use and ask a doctor if

• new symptoms occur
• coughs persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. 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

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

SUPRESS DM 
dextromethorphan hydrobromide, guaifenesin syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52083-058
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	50 mg  in 1 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	CHERRY (SWEET CHERRY)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52083-058-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/02/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/02/2013

Labeler - KRAMER NOVIS (090158395)

Registrant - KRAMER NOVIS (090158395)