SAFETUSSIN PM NIGHTTIME COUGH RELIEF- dextromethorphan hbr, doxylamine succinate liquid

Safetussin PM Nighttime by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

• Active ingredients (in each 5mL):

  Purpose

• Dextromethorphan HBr, USP 7.5 mg:

  Cough Suppressant

• Doxylamine Succinate 3.125 mg:

  Antihistamine

Uses

• temporarily relieves cough
• runny nose and sneezing

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.

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

ASK DOCTOR/PHARMACIST

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

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

STOP USE

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.

PREGNANCY OR BREAST FEEDING

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 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

INACTIVE INGREDIENT

Inactive ingredients:

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

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)

PACKAGE LABEL FOR 4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

SAFETUSSIN PM NIGHTTIME   COUGH RELIEF
dextromethorphan hbr, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-221
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN (UNII: 7355X3ROTS) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	7.5 mg  in 5 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	3.125 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
MINT (UNII: FV98Z8GITP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55505-221-33	1 in 1 CARTON	07/28/2023
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 55505-221-36	1 in 1 CARTON	07/28/2023
2		237 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 Drug	M012	07/28/2023

Labeler - Kramer Laboratories (122720675)