SAFETUSSIN DM- dextromethorpan guaifenesin liquid

Safetussin by

Drug Labeling and Warnings

Safetussin by is a Otc medication manufactured, distributed, or labeled by Kramer Laboratories, Denison Pharmecuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active ingredients (in each 5ml tsp): Purpose
• Dextromethorphan HBr,USP 10 mg: Cough 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

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.

NURSING MOTHERS

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

KEEP OUT OF REACH OF CHILDREN

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

• age: dose
• adults and children12 years and over: 2 teaspoons; every 4 hours
• children under 12 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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Safetussin DM 
NON-DROWSY
DAY TIME
COUGH RELIEF

Cough Suppressant / Expectorant

Specially formulated for adults with

High Blood Pressure
Diabetes

Relieves Cough
Loosens Mucus

No Sugar
No Dyes
No Gluten
No Alcohol

4 FL. OZ (118 ml.)

Safetussin DM 

ALIVIA LA TOS
DURANTE EL DIA

Antitusivo / Expectorante

SEGURO para los que padecen de

Presión alta
Diabetes

Alivia la tos
Descongestiona
el pecho

SIN AZÚCAR
Sin Colorantes
Sin Gluten
Sin Alcohol

4 FL. OZ (118 ml.)

NON-DROWSY
COUGH RELIEF
TO HELP YOU GET 
THROUGH THE DAY

Pharmacist Recommended

Developed by a pharmacist who recognized the need for simple, safe cough relief for adults afflicted with high blood pressure, diabetes or the common cold.

Specially-formulated Safetussin® is free of alcohol, sugar, dyes, decongestants and other ingredients that are unnecessary for safe, adult-strength cough treatment. Pure and simple.

Questions? Comments?
Call 1-800-824-4894 ● safetussin.com

©2019 Kramer Laboratories, Inc.
Bridgewater, NJ 08807 ● kramerlabs.com

K0519

Safetussin® DM 
NON-DROWSY
DAY TIME
COUGH RELIEF

COUGH SUPPRESSANT/ EXPECTORANT

Specially formulated for adults with

High Blood Pressure
Diabetes

Relieves Cough
Loosens Mucus

4 FL. OZ. (118 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON BOTTLE IS BROKEN OR MISSING.

K0519

www.kramerlabs.com ● www.safetussin.com
©2019 Kramer Laboratories, Inc. Bridgewater, NJ 08807

INGREDIENTS AND APPEARANCE

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		118 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)