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Safetussin PM by Kramer Laboratories

Dosage form: liquid
Ingredients: Dextromethorphan 7.5mg in 5mL, DOXYLAMINE SUCCINATE 3.125mg in 5mL
Labeler: Kramer Laboratories
NDC Code: 55505-173

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 7.5 mg Cough Suppressant
Doxylamine Succinate 3.125 mg Antihistamine

Uses
  • temporarily relieves cough
  • runny nose and sneezing

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. • to make a child sleep.

Ask a doctor before use if you have
  • asthma
  • emphysema
  • glaucoma
  • excessive phlegm (mucus)
  • breathing problem
  • chronic bronchitis
  • persistent or chronic cough
  • cough associated with smoking
  • trouble urinating due to enlarged prostate gland
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product
  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives and tranquilizers may increase drowsiness

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 4 doses in any 24-hour period
age dose
adults and children 12 years and over 4 teaspoons every 6 hours
children 4 to 12 years ask a doctor
children under 4 years do 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® PM 
NIGHT TIME COUGH RELIEF

COUGH SUPPRESSANT/ ANTIHISTAMINE

Controls Cough
Relieves Sneezing & Runny Nose

SAFE For Those With:
High Blood Pressure
Diabetes

SUGAR FREE

Dye Free
Gluten Free
Alcohol Free

4 FL. OZ (120 mL)

Safetussin® PM 
ALIVIA LA TOS DURANTE LA NOCHE

Calma la tos
Alivia estomudos & goteo de la nariz

SEGURO para los que padecen de:
Presión alta
Diabetes

SIN AZÚCAR

Sin Colorantes
Sin Gluten
Sin Alcohol

4 FL. OZ (120 mL)

Up To 8 Hours Of Cough Relief To Help You Rest

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

KRAMER
CONSUMER HEALTHCARE
A division of Kramer Laboratories

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

k0916

Safetussin® PM 
NIGHT TIME COUGH RELIEF

COUGH SUPPRESSANT/ ANTIHISTAMINE

Controls Cough
Relieves Sneezing & Runny Nose

SAFE For Those With:
High Blood Pressure
Diabetes

4 FL. OZ. (120 mL)

KRAMER
CONSUMER HEALTHCARE
A division of Kramer Laboratories

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

k0916

SAFETUSSIN   PM
dextromethorphan doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-173
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan (Dextromethorphan) Dextromethorphan Hydrobromide7.5 mg  in 5 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE3.125 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Aspartame 
benzoic acid 
CITRIC ACID MONOHYDRATE 
glycerin 
menthol 
methylparaben 
MINT 
propylene glycol 
propylparaben 
water 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55505-173-331 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 finalpart34102/09/2017
Labeler - Kramer Laboratories (122720675)
Establishment
NameAddressID/FEIOperations
Denison Pharmecuticals001207208manufacture(55505-173)

Revised: 02/2017
 
Kramer Laboratories

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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