Label at a glance#

ProductSAFETUSSIN Non Drowsy Cough plus chest congestion

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN

Label structure11 sections

Indications and uses

▪ temporarily relieves cough due to minor throat and bronchial irritation ▪ loosen phlegm (mucus) ▪ helps rid bronchial passages of phlegm(mucus)

Dosage and administration

▪ do not take more than 6 doses in any 24-hours period ▪ This adult product is not intended for use in children under 12 years of age age dose Adults and children 12 years and over 10 mL every 4 hours Children under 12 years do not use

Storage and handling

▪ Protect from excessive heat and freezing. Store at 15° - 30°C (59° - 86°F) Save this package for complete information

Contacts and useful links#

PhoneLabel contact1-800-824-4894

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

*Active ingredients (in each 5 mL)*	*Purpose*
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 100 mg	Expectorant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than 6 doses in any 24-hours period
This adult product is not intended for use in children under 12 years of age

age	dose
Adults and children 12 years and over	10 mL every 4 hours
Children under 12 years	do not use

Other information

STORAGE AND HANDLING SECTION

Protect from excessive heat and freezing.
Store at 15° - 30°C (59° - 86°F)

Save this package for complete information

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, glycerin, menthol, natural peppermint flavor, propylene glycol, purified water, sodium benzoate, sucralose,

Questions? Comments?

OTC - QUESTIONS SECTION

Call 1-800-824-4894

SPL UNCLASSIFIED SECTION

Distributed by

PRINCIPAL DISPLAY PANEL - 237 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SAFE FOR ADULTS WITH
HIGH BLOOD PRESSURE & DIABETES

Safe
tussin^®

DM

NON-DROWSY
Cough + Chest
Congestion

Dextromethorphan HBr 10mg / Cough Suppressant
Guaifenesin 100mg / Expectorant

Safe for adults with

● High Blood Pressure
● Diabetes

✓ Controls cough
✓ Loosens mucus
✓ Relieves chest congestion

SUGAR & ALCOHOL FREE

8.0 FL OZ (237mL)

SEGURO PARA ADULTOS CON
PRESIÓN ALTA Y DIABETES

Safe
tussin^®

DM

NO SOMNOLIENTO
Tos + Congestión
en el Pecho

Dextromethorphan HBr 10mg / Antitusivo
Guaifenesin 100mg / Expectorante

Seguro para adultos con

● Presión Alta
● Diabetes

✓ Controla la tos
✓ Afloja la muscosidad
✓ Alivia la congestion en el pecho

SIN AZÚCAR Y SIN ALCOHOL

8.0 FL OZ (237mL)

SAFE FOR ADULTS WITH
HIGH BLOOD PRESSURE & DIABETES

Safe
tussin^®

DM

NON-DROWSY
Cough + Chest
Congestion

Safetussin^® contains:
✓ No decongestants
✓ No acetaminophen
✓ No sugar
✓ No alcohol
✓ No sorbitol
✓ No fructose
✓ No gluten
✓ No dyes

Pharmacist Recommended Brand

Always read and follow label directions.
Do not use longer than 7 consecutive days
unless directed by a doctor. Ask a doctor
if you have individual health questions.

Questions? Comments? Call 1-800-824-4894
©2020 Kramer Laboratories, Inc., Bridgewater, NJ 08807

K0423

Safetussin Non Drowsy Cough plus chest congestion 8 FL OZ (237 ml)

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SAFE FOR ADULTS WITH
HIGH BLOOD PRESSURE & DIABETES

Safe
tussin^®

DM

clear
sugar free
syrup

Cough + Chest
Congestion

Dextromethorphan HBr 10mg / Cough Suppressant
Guaifenesin 100mg / Expectorant

Safe for adults with

● High Blood Pressure
● Diabetes

✓ Controls cough
✓ Loosens mucus
✓ Relieves chest congestion

SUGAR & ALCOHOL FREE

4.0 FL OZ (118mL)

SEGURO PARA ADULTOS CON
PRESIÓN ALTA Y DIABETES

Safe
tussin^®

DM

almíbar
claro sin
azúcar

Tos + Congestión
en el Pecho

Dextromethorphan HBr 10mg / Antitusivo
Guaifenesin 100mg / Expectorante

Seguro para adultos con

● Presión Alta
● Diabetes

✓ Controla la tos
✓ Afloja la muscosidad
✓ Alivia la congestion en el pecho

SIN AZÚCAR Y SIN ALCOHOL

4.0 FL OZ (118mL)

SAFE FOR ADULTS WITH
HIGH BLOOD PRESSURE & DIABETES

Safe
tussin^®

DM

clear
sugar free
syrup

Cough + Chest Congestion

Safetussin^® contains:
✓ No decongestants
✓ No acetaminophen
✓ No sugar
✓ No alcohol
✓ No sorbitol
✓ No fructose
✓ No gluten
✓ No dyes

Pharmacist Recommended Brand

Always read and follow label directions.
Do not use longer than 7 consecutive days
unless directed by a doctor. Ask a doctor if
you have individual health questions.

Questions? Comments? Call 1-800-824-4894
©2020 Kramer Laboratories, Inc., Bridgewater, NJ 08807

K1124

TAMPER-EVIDENT: DO NOT USE IF PRINTED
INNER SEAL UNDER CAP IS TORN OR MISSING.

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEXTROMETHORPHAN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55505-220-33	SAFETUSSIN Non DrowsyCough plus chest congestion	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118		5
55505-220-36	SAFETUSSIN Non DrowsyCough plus chest congestion	237 mL in 1 BOTTLE, PLASTIC	LIQUID	237		5

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

SAFETUSSIN Non Drowsy Cough plus chest congestion
Dextromethorphan Hydrobromide, and Guaifenesin
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
GUAIFENESIN
CITRIC ACID MONOHYDRATE
GLYCERIN
MENTHOL, UNSPECIFIED FORM
MINT
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SUCRALOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55505-220	55505-220-33, 55505-220-36

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
GUAIFENESIN	495W7451VQ	ACTIB
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
GLYCERIN	PDC6A3C0OX	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	IACT
MINT	FV98Z8GITP	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SUCRALOSE	96K6UQ3ZD4	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SAFETUSSIN Non Drowsy Cough plus chest congestion	DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN	KRAMER LABORATORIES	60311ca3-8544-417e-aa29-e9f65c6692ba	2025-06-11	Warnings	Exact identifier ndc (package): 55505-220-36 ndc (package): 55505-220-33 ndc (product): 55505-220 ndc11 (package): 55505022033 ndc11 (package): 55505022036 spl id: cff65bfa-6667-4ecf-a98c-a93b50d2d161 spl set id: 60311ca3-8544-417e-aa29-e9f65c6692ba

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.