safetussin pm nighttime cough relief drug facts

Drug Facts

Composition & Product

Active Ingredients

doxylamine (7.5 mg)

Inactive Ingredients

citric acid monohydrate glycerin menthol, unspecified form mint propylene glycol water sodium benzoate sucralose

Identifiers & Packaging

Marketing Status

otc monograph drug completed Since 2023-07-28 Until 2025-10-30

Medication Information

Warnings

Do not useif 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.

Uses

temporarily relieves cough
runny nose and sneezing

Directions

do not take more than 4 doses in any 24-hour period

age	dose
adults and children 12 years and over	20 mL every 6 hours
children under 12 years	ask a doctor
children under 4 years	do not use

Description

Active ingredients (in each 5mL) Purpose Dextromethorphan HBr, USP 7.5 mg Cough Suppressant Doxylamine Succinate 3.125 mg Antihistamine

Principal Display Panel

SAFE FOR ADULTS WITH

HIGH BLOOD PRESSURE & DIABETES

Safetussin ^®PM

NightTime

Cough Relief

Dextromethorphan HBr 7.5 mg / Cough Suppressant

Doxylamine Succinate 3.125 mg / Antihistamine

Safe for adults with

High Blood Pressure

Diabetes

√ Controls Cough

√ Relieves Sneezing

√ Relieves runny nose

SUGAR & ALCOHOL FREE

4.0 FL OZ (118mL)

SEGURO PARA ADULTOS CON PRESION ALTA Y DIABETES

Safetussin ^®PM

Alivia la Tos

Durante la Noche

Dextromethorphan HBr 7.5 mg / Antiusivo

Doxylamine Succinate 3.125 mg / Antihistaminíco

Seguro para adultos con

Presión Alta

Diabetes

√ Calma la tos,

√ Alivia estornudos

√ Alivia goteo de la nariz

SINAZÚCAR Y SINALCOHOL

4 FL. OZ (118 mL)

Safetussin ^®PM

NIGHT TIME

COUGH RELIEF

Cough Suppressant / Antihistamine

Up To

8 Hours of cough relief

to help you rest

Safetussin ^®PM 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

© 2023 Kramer Laboratories, Inc.

Bridgewater, NJ 08807 ● kramerlabs.com

K0723

PACKAGE LABEL FOR 4 FL OZ (118 mL)

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 50566-9

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50568-5

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

Section 51727-6

Inactive ingredients :

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

Section 53414-9

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

Section 55105-1

Active ingredients (in each 5mL)	Purpose
Dextromethorphan HBr, USP 7.5 mg	Cough Suppressant
Doxylamine Succinate 3.125 mg	Antihistamine

Other Information:

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

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

Package Label for 4 Fl Oz (118 Ml)

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

Structured Label Content

Warnings

Do not useif 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.

Uses

temporarily relieves cough
runny nose and sneezing

Directions

do not take more than 4 doses in any 24-hour period

age	dose
adults and children 12 years and over	20 mL every 6 hours
children under 12 years	ask a doctor
children under 4 years	do not use

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

SAFE FOR ADULTS WITH

HIGH BLOOD PRESSURE & DIABETES

Safetussin ^®PM

NightTime

Cough Relief

Dextromethorphan HBr 7.5 mg / Cough Suppressant

Doxylamine Succinate 3.125 mg / Antihistamine

Safe for adults with

High Blood Pressure

Diabetes

√ Controls Cough

√ Relieves Sneezing

√ Relieves runny nose

SUGAR & ALCOHOL FREE

4.0 FL OZ (118mL)

SEGURO PARA ADULTOS CON PRESION ALTA Y DIABETES

Safetussin ^®PM

Alivia la Tos

Durante la Noche

Dextromethorphan HBr 7.5 mg / Antiusivo

Doxylamine Succinate 3.125 mg / Antihistaminíco

Seguro para adultos con

Presión Alta

Diabetes

√ Calma la tos,

√ Alivia estornudos

√ Alivia goteo de la nariz

SINAZÚCAR Y SINALCOHOL

4 FL. OZ (118 mL)

Safetussin ^®PM

NIGHT TIME

COUGH RELIEF

Cough Suppressant / Antihistamine

Up To

8 Hours of cough relief

to help you rest

Safetussin ^®PM 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

© 2023 Kramer Laboratories, Inc.

Bridgewater, NJ 08807 ● kramerlabs.com

K0723

PACKAGE LABEL FOR 4 FL OZ (118 mL)

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 50566-9 (50566-9)

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50568-5 (50568-5)

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

Section 51727-6 (51727-6)

Inactive ingredients :

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

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 5mL)	Purpose
Dextromethorphan HBr, USP 7.5 mg	Cough Suppressant
Doxylamine Succinate 3.125 mg	Antihistamine

Other Information: (Other information:)

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

When Using This Product (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

Package Label for 4 Fl Oz (118 Ml) (PACKAGE LABEL FOR 4 FL OZ (118 mL))

Ask A Doctor Before Use If You Have (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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves cough runny nose and sneezing", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "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.", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.", "51727-6": "Inactive ingredients : citric acid, glycerin, menthol, natural peppermint flavor, propylene glycol, purified water, sodium benzoate, sucralose", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each 5mL) Purpose Dextromethorphan HBr, USP 7.5 mg Cough Suppressant Doxylamine Succinate 3.125 mg Antihistamine", "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.", "Directions": "do not take more than 4 doses in any 24-hour period age dose adults and children 12 years and over 20 mL every 6 hours children under 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) Save this package for complete information", "PRINCIPAL DISPLAY PANEL": "SAFE FOR ADULTS WITH HIGH BLOOD PRESSURE & DIABETES Safetussin ® PM NightTime Cough Relief Dextromethorphan HBr 7.5 mg / Cough Suppressant Doxylamine Succinate 3.125 mg / Antihistamine Safe for adults with High Blood Pressure Diabetes √ Controls Cough √ Relieves Sneezing √ Relieves runny nose SUGAR & ALCOHOL FREE 4.0 FL OZ (118mL) SEGURO PARA ADULTOS CON PRESION ALTA Y DIABETES Safetussin ® PM Alivia la Tos Durante la Noche Dextromethorphan HBr 7.5 mg / Antiusivo Doxylamine Succinate 3.125 mg / Antihistaminíco Seguro para adultos con Presión Alta Diabetes √ Calma la tos, √ Alivia estornudos √ Alivia goteo de la nariz SIN AZÚCAR Y SIN ALCOHOL 4 FL. OZ (118 mL) Safetussin ® PM NIGHT TIME COUGH RELIEF Cough Suppressant / Antihistamine Up To 8 Hours of cough relief to help you rest Safetussin ® PM 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 © 2023 Kramer Laboratories, Inc. Bridgewater, NJ 08807 ● kramerlabs.com K0723 PACKAGE LABEL FOR 4 FL OZ (118 mL)", "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", "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"}