PSEUDO EPHED PLUS- pseudoephedrine hydrochloride, guaifenesin tablet

Pseudo Ephed Plus by

Drug Labeling and Warnings

Pseudo Ephed Plus by is a Otc medication manufactured, distributed, or labeled by Dickey Consumer Products DBA DMD, Ultratab Laboratories, Inc., Ultra Seal Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient(In Each Tablet): Pseudoephedrine HCl 30 mg, Guaifenesin 200 mg

PURPOSE

Purposes - Nassal Decongestant, Expectorant

INDICATIONS & USAGE

temporarily relieves nasal congestion due to the common cold promotes nasal and/or sinus drainage temporarily relieves sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

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: heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema a cough accompanied by excessive phlegm (mucus)

When using this product do not use more than directed intentional abuse of this product can be harmful or fatal

Stop use and ask a doctor if: you get nervous dizzy or sleepless cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. symptoms do not get better within 7 days or occur with a fever

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding, ask a health proffessional 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.

DOSAGE & ADMINISTRATION

adults and children 12 years of age and over: take 2 tablets every 4 to 6 hours; do not exceed 8 tablets in 24 hours children under 12 years of age: ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients: Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Stearic Acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PSEUDO EPHED PLUS 
pseudoephedrine hydrochloride, guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65193-325
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K30 (UNII: U725QWY32X)
STEARIC ACID (UNII: 4ELV7Z65AP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Product Characteristics
Color	white (snow white)	Score	no score
Shape	ROUND (EP230)	Size	9mm
Flavor		Imprint Code	EP230
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65193-325-24	24 in 1 BLISTER PACK; Type 0: Not a Combination Product	03/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/15/2019

Labeler - Dickey Consumer Products DBA DMD (835974056)

Registrant - Dickey Consumer Products DBA DMD (835974056)

Establishment
Name	Address	ID/FEI	Business Operations
Ultratab Laboratories, Inc.		151051757	manufacture(65193-325)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corp.		085752004	pack(65193-325)