Safetussin Non-drowsy Cough And Chest Drug Facts

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (10 mg) Guaifenesin (100 mg)

Inactive Ingredients

Citric Acid Monohydrate Glycerin Menthol, Unspecified Form Mint Propylene Glycol Water Sodium Benzoate Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-06-01

Medication Information

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

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

Section 53414-9

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

Section 55105-1

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

Directions

▪
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

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.

Other Information

▪
Protect from excessive heat and freezing.

Store at 15° - 30°C (59° - 86°F)

Save this package for complete information

Inactive Ingredients

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

Questions? Comments?

Call 1-800-824-4894

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.

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

Principal Display Panel 118 Ml Bottle Label

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.

Principal Display Panel 237 Ml Bottle Label

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

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

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

Directions

▪
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

Do Not Use (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.

Other Information (Other information)

▪
Protect from excessive heat and freezing.

Store at 15° - 30°C (59° - 86°F)

Save this package for complete information

Inactive Ingredients (Inactive ingredients)

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

Questions? Comments?

Call 1-800-824-4894

Stop Use and Ask A Doctor If (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.

Ask A Doctor Before Use If You Have (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

Principal Display Panel 118 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label)

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.

Principal Display Panel 237 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 237 ml Bottle Label)

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

Advanced Ingredient Data

[{"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINT", "unii": "FV98Z8GITP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "▪ temporarily relieves cough due to minor throat and bronchial irritation ▪ loosen phlegm (mucus) ▪ helps rid bronchial passages of phlegm(mucus)", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "53414-9": "If pregnant or breast-feeding , ask a health professional before use.", "55105-1": "Active ingredients (in each 5 mL) Purpose Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 100 mg Expectorant", "Directions": "▪ 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", "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.", "Other information": "▪ Protect from excessive heat and freezing. Store at 15° - 30°C (59° - 86°F) Save this package for complete information", "Inactive ingredients": "citric acid, glycerin, menthol, natural peppermint flavor, propylene glycol, purified water, sodium benzoate, sucralose,", "Questions? Comments?": "Call 1-800-824-4894", "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.", "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", "PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label": "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 l a 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.", "PRINCIPAL DISPLAY PANEL - 237 ml Bottle Label": "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 l a 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 And Chest Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information