SAFETUSSIN PM- dextromethorphan doxylamine succinate liquid

Safetussin by

Drug Labeling and Warnings

Safetussin by is a Otc medication manufactured, distributed, or labeled by Denison Pharmaceuticals, LLC.. 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, USP 3.125 mg: Expectorant

USES

Cough Suppressant


Antihistamine

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE

• temporarily relieves coughgh runny nose and sneezing

DOSAGE & ADMINISTRATION

• 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

INACTIVE INGREDIENT

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

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. 

Ask a Doctor

Before you use if you have:

• Asthma
• emphysema
• glaucoma
• excessive phlem (mucus)
• breathing problem
• chronic bronchitis
• persisten or chronic cough
• cough associated with smoking
• trouble urinating do to enlarged prostate gland
• a sodium restricted diet

ASK DOCTOR/PHARMACIST

If you are taking sedatives or tranquilizers.

WHEN USING

• do not use more than directed
• excitability may occur, specially in children
• marked drowsiness may occur
• avoid alcoholic drinks
• be careful when driing
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives and tranquilizers may increase drowsiness

STOP USE

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 serious conditions.

OTHER INFORMATION

• Protect from excessive heat and freezing. Store at 15° - 30° C (59° - 86° F)
• Phenylketonurics: each teaspoon contains phenylalanine 4.2 mg

Safe this package for complete information

SAFETUSSIN PM (DEXTROMETHORPHAN DOXYLAMINE SUCCINATE) LIQUID

INGREDIENTS AND APPEARANCE

SAFETUSSIN  PM
dextromethorphan doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-5307
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (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, UNSPECIFIED FORM (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: 0295-5307-17	1 in 1 CARTON	01/01/2017
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0295-5307-28	1 in 1 CARTON	01/01/2017	11/07/2019
2		240 mL in 1 BOTTLE; 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	01/01/2017

Labeler - Denison Pharmaceuticals, LLC. (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC.		001207208	manufacture(0295-5307)