SAFETUSSIN DM- dextromethorpan guaifenesin 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 10 mg: Cough Suppressant
• Guaifenesin, USP 100 mg: Expectorant

Uses

• temporarily relieves cough due to minor throat and bronchial irritation
• loosens phlegm (mucus)
• helps rid bronchial passages of phlegm (mucus)

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 use if you have

• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

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.

NURSING MOTHERS

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 6 doses in any 24-hour period
• this adult product is not intended for use in children under 12 years of age

• age: dose
• adults and children 12 years and over: 2 teaspoons ; every 4 hours
• children under 12 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

SAFETUSSIN DM (DEXTROMETHORPAN GUAIFENESIN) LIQUID

INGREDIENTS AND APPEARANCE

SAFETUSSIN  DM
dextromethorpan guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-1111
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINT (UNII: FV98Z8GITP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-1111-17	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2017
2	NDC: 0295-1111-28	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2017	11/11/2019

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(0295-1111)