EPHED PLUS LIQUID- ephedrine guaifenesin liquid

Ephed Plus Liquid by

Drug Labeling and Warnings

Ephed Plus Liquid by is a Otc medication manufactured, distributed, or labeled by Dickey Consumer Products DBA DMD, Ultraseal Corporation, ULTRAtab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

Warnings

PURPOSE

Purpose: Bronchodilator, Expectorant

INDICATIONS & USAGE

Uses  for temporary relief of mild symptoms of intermittent asthma:  wheezing
tightness of chest , shortness of breath , helps loosen phlegm (mucus) and thin
bronchial secretions to rid bronchial passageways of bothersome mucus, and to make
coughs more productive

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health
professional before use

DOSAGE & ADMINISTRATION

Directions do not take more than directed

­ adults and children 12 years of age and over: take 1

bottle every 4 hours as needed. Do not take more than

6 bottles in 24 hours ­ children under 12 years of age:

do not use

INACTIVE INGREDIENT

Inactive ingredients Blue #1, Citric Acid,
Filtered Water, Malic Acid, Natural and Artificial Flavors,
Potassium Sorbate, Propylene Glycol, Sodium

ACTIVE INGREDIENT

Ephedrine HCI 25 mg, Bronchodilator
Guaifenesin 400 mg, Expectorant

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EPHED PLUS LIQUID 
ephedrine guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65193-180
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EPHEDRINE HYDROCHLORIDE (UNII: NLJ6390P1Z) (EPHEDRINE - UNII:GN83C131XS)	EPHEDRINE HYDROCHLORIDE	25 mg  in 60 mL
guaifenesin (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	guaifenesin	400 mg  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MALIC ACID (UNII: 817L1N4CKP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	purple (purple)	Score
Shape		Size
Flavor	grape	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65193-180-57	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/10/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/10/2017

Labeler - Dickey Consumer Products DBA DMD (835974056)

Registrant - Dickey Consumer Products DBA DMD (835974056)

Establishment
Name	Address	ID/FEI	Business Operations
Ultraseal Corporation		085752004	pack(65193-180)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab Laboratories, Inc.		151051757	manufacture(65193-180)