SAFETUSSIN DM - dextromethorpan guaifenesin liquid 
Kramer Laboratories

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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Drug Facts

Active ingredients (in each 5ml tsp) Purpose
Dextromethorphan HBr,USP 10 mg Cough Suppressant
Guaifenesin, USP 100 mg Expectorant

Uses

Warnings

Do not use 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 the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

Stop use and ask a doctor if 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.

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

age dose
adults and children
12 years and over
2 teaspoons
every 4 hours
children under 12 years do not use

Other information:

Save this package for complete information

Inactive ingredients: aspartame, benzoic acid, citric acid, glycerin, menthol, methylparaben, natural peppermint flavor, propylene glycol, propylparaben, purified water

PRINCIPAL DISPLAY PANEL

Safetussin® DM 
DAY TIME COUGH RELIEF

COUGH SUPPRESSANT/ EXPECTORANT
Relieves Cough
Loosens Mucus

SAFE For Those With:
High Blood Pressure
Diabetes

SUGAR FREE

Dye Free
Gluten Free
Alcohol Free

4 FL. OZ (120 ml.)

Safetussin® DM 

Alivia la tos
Descongestiona el Pecho

SEGURO para los que padecen de:
Presión alta
Diabetes

SIN AZÚCAR

Sin Colorantes
Sin Gluten
Sin Alcohol

4 FL. OZ (120 ml.)

NON-DROWSY

Safe Cough Relief
Pure and Simple

Safetussin® was developed by a pharmacist who recognized the special needs of many of his customers afflicted with high blood pressure, diabetes, and those looking for simple, safe cough relief.

Safetussin is specially formulated, free of alcohol, sugar, dyes, decongestants and other unwanted ingredients that are not needed for safe, adult strength cough treatment.

The Clear Choice!

Pharmacist Recommended

Dosage Cup Included
Vaso Dosificador Incluido

Distributed by/ Distribuido por
KRAMER
CONSUMER HEALTHCARE
A division of Kramer Laboratories

www.safetussin.com
www.kramerconsumerhealthcare.com

Coral Gables, FL 33134
1-800-824-4894

k0916

carton

Safetussin® DM 
DAY TIME COUGH RELIEF

COUGH SUPPRESSANT/ EXPECTORANT

High Blood Pressure
Diabetes

4 FL. OZ. (120 mL)

KRAMER
CONSUMER HEALTHCARE
A division of Kramer Laboratories

Coral Gables, FL 33134
www.kramerlabs.com
www.safetussin.com

k0916

label
SAFETUSSIN  DM
dextromethorpan guaifenesin liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55505-111
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Aspartame (UNII: Z0H242BBR1)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
glycerin (UNII: PDC6A3C0OX)  
methylparaben (UNII: A2I8C7HI9T)  
MINT (UNII: FV98Z8GITP)  
propylene glycol (UNII: 6DC9Q167V3)  
propylparaben (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Menthol (UNII: L7T10EIP3A)  
Product Characteristics
Color      Score     
Shape Size
Flavor MINT Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55505-111-33 1 in 1 CARTON 02/10/2017
1 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 11/29/2010
Labeler - Kramer Laboratories (122720675)
Establishment
Name Address ID/FEI Business Operations
Denison Pharmecuticals 001207208 manufacture(55505-111)

Revised: 2/2017
Document Id: 6569b0ca-49d0-4540-b6de-1e2f260899a2
Set id: ac9f25a7-03cc-461b-af3e-8c16b7146a22
Version: 6
Effective Time: 20170208
 
Kramer Laboratories