EPHED 60- pseudoephedrine liquid
Dickey Consumer Products DBA DMD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

Active Ingredient (In Each Bottle)---Pseudoephedrine HCl 60 mg

Purpose-Nasal Decongestant

Do not exceed recommended dosage. If dizziness or sleeplessness occur, symptoms do not improve or are accompanied by a fever-consult a doctor.

Do not exceed recommended dosage. If dizziness or sleeplessness occur, consult a doctor.

Drug interaction Precaution: Do not use this product 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 are uncertain whether your prescription drug contains an MAOI, consult a health professional before using this product.

Keep out of reach of children

if pregnant or breast feeding a baby, consult a health professional before use.

Inactive Ingredients: Acesulfame Potassium, Citric acid, filtered water, malic acid, natural flavors, potassium citrate, sodium benzoate, sucralose

Adults and children 12 years of age and older: 1 bottle every 4-6 hours. Do not exceed 4 bottles in 24 hours. Children under 12: Do not use

For the temporary relief of nasal decongestiom due to the commomn cold, hay fever or other upper respiratpry allergies. Temporarily relieves nasal stuffiness. Decongests nasal passages: shrinks swollen membranes. Temporarily restores freer breathing through the nose. Helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure. Promotes nasal and/or sinus drainage. temporarily relieves sinus congestion and pressure.

ephed 60

EPHED 60
pseudoephedrine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65193-939
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg in 60 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SUCRALOSE (UNII: 96K6UQ3ZD4)
MALIC ACID (UNII: 817L1N4CKP)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Characteristics
Color	red (BERRY RED)	Score
Shape		Size
Flavor	BERRY (LIQUID BERRY FLAVOR)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65193-939-57	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/10/2011	11/15/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	10/10/2011	11/15/2018

Labeler - Dickey Consumer Products DBA DMD (835974056)

Registrant - Dickey Consumer Products DBA DMD (835974056)

Name	Address	ID/FEI	Business Operations
Establishment
Ultratab Laboratories, Inc.		151051757	manufacture(65193-939)

Name	Address	ID/FEI	Business Operations
Establishment
Ultra Seal Corporation		085752004	pack(65193-939)

Revised: 11/2018

Document Id: 66a9f5f2-42e8-4500-a1f4-d4eb4e86758b

Set id: 00023ca2-4433-4f88-8252-bc8c1d7ea2e0

Version: 2

Effective Time: 20181115

Dickey Consumer Products DBA DMD