FDA.reportPublic FDA data

Safetussin PM Nighttime

Manufacturer
Kramer Laboratories
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:29:07

Label at a glance#

ProductSafetussin PM Nighttime Cough relief
Active ingredientDEXTROMETHORPHAN, DOXYLAMINE SUCCINATE
Label structure13 sections

Indications and uses

temporarily relieves cough runny nose and sneezing

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 5mL)

Purpose

Dextromethorphan HBr, USP 7.5 mg

Cough Suppressant

Doxylamine Succinate 3.125 mg

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves cough
  • runny nose and sneezing

Warnings

WARNINGS SECTION

  • 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

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.

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 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:

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 INGREDIENT SECTION

Inactive ingredients:

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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)

Safetussin PM NightTime Cough Relief 4.0 FL OZ (118 mL)
Safetussin PM NightTime Cough Relief 4.0 FL OZ (118 mL)

PACKAGE LABEL FOR 4 FL OZ (118 mL)

SPL UNCLASSIFIED SECTION

Safetussin PM NightTime Cough Relief 8.0 FL OZ (237 mL)
Safetussin PM NightTime Cough Relief 8.0 FL OZ (237 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115329dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral SolutionPSN4
1115329dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral SolutionSCD4
1115329dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral SolutionSY4
1115329dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral SolutionSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55505-221-33Safetussin PM NighttimeCough relief118 mL in 1 BOTTLE, PLASTICLIQUID1184
55505-221-33Safetussin PM NighttimeCough relief1 in 1 CARTONLIQUID14
55505-221-36Safetussin PM NighttimeCough relief237 mL in 1 BOTTLE, PLASTICLIQUID2374
55505-221-36Safetussin PM NighttimeCough relief1 in 1 CARTONLIQUID14

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55505-22155505-221-33, 55505-221-36

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
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
MINTFV98Z8GITPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
DEXTROMETHORPHAN7355X3ROTSACTIR
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Safetussin PM Nighttime Cough reliefDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKramer Laboratories33dd2245-9abd-4b32-ac76-0f45a54c0f332025-12-29WarningsExact identifier
ndc (package): 55505-221-33
ndc (package): 55505-221-36
ndc (product): 55505-221
ndc11 (package): 55505022133
ndc11 (package): 55505022136
spl id: b7fd290f-7f8e-430f-8bbf-b5aeea4181de
spl set id: 33dd2245-9abd-4b32-ac76-0f45a54c0f33

Reported adverse events (FAERS/openFDA)#

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