SAFETUSSIN PM- dextromethorphan doxylamine succinate liquid

Safetussin by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

• Active ingredients (in each 5ml tsp): 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 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.

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 if you 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 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.

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: 4 teaspoons ; every 6 hours
• children 4 to 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)
• Phenylketonurics: each teaspoon contains phenylalanine 4.2 mg

Save this package for complete information

INACTIVE INGREDIENT

Inactive ingredients: aspartame, benzoic acid, citric acid, glycerin, menthol, methylparaben, natural peppermint flavor, propylene glycol, propylparaben, purified water

PRINCIPAL DISPLAY PANEL

Safetussin® PM 
NIGHT TIME
COUGH RELIEF
Cough Suppressant / Antihistamine

Specially formulated for adults with

High Blood Pressure
Diabetes

Controls Cough
Relieves Sneezing
& Runny Nose

No Sugar
No Dyes 
No Gluten
No Alcohol

4.0 FL OZ (118mL)

Safetussin® PM
ALIVIA LA TOS
DURANTE LA NOCHE
Antiusivo / Antihistaminíco

SEGURO para los que padecen de

Presión alta
Diabetes

Calma la tos,
alivia estornudos
y goteo de la nariz
 
Sin Azúcar
Sin Colorantes
Sin Gluten
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

Pharmacist Recommended

Developed by a pharmacist who recognized the need for simple, safe cough relief for adults afflicted with high blood pressure, diabetes or the common cold.

Specially-formulated Safetussin® is free of alcohol, sugar, dyes, decongestants and other ingredients that are unnecessary for safe, adult-strength cough treatment. Pure and simple.

Questions? Comments?
Call 1-800-824-4894 ● safetussin.com

© 2019 Kramer Laboratories, Inc.
Bridgewater, NJ 08807 ● kramerlabs.com

k0519

Safetussin® PM
NIGHT TIME
COUGH RELIEF
Cough Suppressant / Antihistamine

Specially formulated for adults with

High Blood Pressure
Diabetes

Controls Cough
Relieves Sneezing & Runny Nose

4 FL. OZ. (118 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON BOTTLE IS BROKEN OR MISSING.

K0519

www.kramerlabs.com ● www.safetussin.com
© 2019 Kramer Laboratories, Inc. Bridgewater, NJ 08807

INGREDIENTS AND APPEARANCE

SAFETUSSIN   PM
dextromethorphan doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-173
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
Aspartame (UNII: Z0H242BBR1)
benzoic acid (UNII: 8SKN0B0MIM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
glycerin (UNII: PDC6A3C0OX)
menthol (UNII: L7T10EIP3A)
methylparaben (UNII: A2I8C7HI9T)
MINT (UNII: FV98Z8GITP)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55505-173-33	1 in 1 CARTON	02/09/2017
1		118 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 final	part341	02/09/2017

Labeler - Kramer Laboratories (122720675)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmecuticals		001207208	manufacture(55505-173)