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Safetussin DM by Kramer Laboratories

Dosage form: liquid
Ingredients: Dextromethorphan Hydrobromide 10mg in 5mL, GUAIFENESIN 100mg in 5mL
Labeler: Kramer Laboratories
NDC Code: 55505-111

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

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

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation
  • loosens phlegm (mucus)
  • helps rid bronchial passages of phlegm (mucus)

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
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

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
  • do not take more than 6 doses in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
agedose
adults and children
12 years and over
2 teaspoons
every 4 hours
children under 12 yearsdo not use

Other information:
  • Protect from excessive heat and freezing. Store at 15° - 30° C (59° - 86° F)
  • Phenylketonurics: each teaspoon contains phenylalanine 4.2 mg

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 DURANTE EL DIA

ANTITUSIVO / EXPECTORANTE

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® 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

Certified
WBENC
Women's Business Enterprise


TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL ON CAP IS BROKEN, TORN OR MISSING

KRAMER LABORATORIES

Coral Gables, FL 33134 ● 1-800-824-4894
www.kramerlabs.com ● www.safetussin.com

K0617

Safetussin® DM 
DAY TIME COUGH RELIEF

COUGH SUPPRESSANT/ EXPECTORANT

SAFE For Those With:
High Blood Pressure
Diabetes

4 FL. OZ. (120 mL)

KRAMER Laborites

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

K0617

SAFETUSSIN  DM
dextromethorpan guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-111
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide10 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Aspartame 
BENZOIC ACID 
Citric Acid Monohydrate 
glycerin 
methylparaben 
MINT 
propylene glycol 
propylparaben 
WATER 
Menthol 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55505-111-331 BOTTLE, PLASTIC in 1 CARTON
1120 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/29/2010
Labeler - Kramer Laboratories (122720675)
Establishment
NameAddressID/FEIOperations
Denison Pharmecuticals001207208manufacture(55505-111)

 
Kramer Laboratories

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Medically reviewed on Jan 16, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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