CONGESTAID II- phenylephrine hydrochloride tablet

Congestaid II by

Drug Labeling and Warnings

Congestaid II by is a Otc medication manufactured, distributed, or labeled by Zee Medical Inc, Ultratab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient/Tablet Phenylephrine HCL 5 mg

PURPOSE

Purpose-Nasal Decongestant

INDICATIONS & USAGE

Temporarily relieves Nasal and sinus congestion due to: the common cold, hay fever, upper respiratory allergies

DOSAGE & ADMINISTRATION

Adults: Take 2 tablets every 4 hours, not to exceed 12 tablets in 24 hours

Children under 12 years, ask a doctor

WARNINGS

    Warnings:
    Do not use:
    more than the recommended dose
    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 MAOI drug. If you do not know if your prescription 
drug contains an MAOI, consult a doctor or pharmacist before 
taking this product
Stop use and ask a doctor if:
    symptoms do not improve
    new symptoms occur
    redness or swelling is present
    nervousness, dizziness or sleeplessness occur
    symptoms do not improve within 7 days or are accompanied by 
fever
Ask a doctor before use if you have:
    heart disease
    high blood pressure
    thyroid disease
    diabetes
    difficulty in urination due to enlargement of the prostate gland

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding baby, 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.  
Prompt medical attention is critical for adults as well as for  
children even if you do not notice any signs or symptoms.

INACTIVE INGREDIENT

Inactive Ingredients: Crosscarmellose Sodium,  DC Red 27, Dicalcium Phosphate, Hypromellose, Magnesium Stearate,
Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Silicon Dioxide, Starch, Stearic Acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CONGESTAID II 
phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35418-334
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
D&C RED NO. 27 (UNII: 2LRS185U6K)

Product Characteristics
Color	white (snow white)	Score	no score
Shape	ROUND (ZEE;CAII)	Size	6mm
Flavor		Imprint Code	ZEE;CAII
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35418-334-68	50 in 1 CARTON	06/12/2012
1	NDC: 35418-334-67	125 in 1 CARTON
1	NDC: 35418-334-02	2 in 1 PACKET; 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	06/12/2012

Labeler - Zee Medical Inc (009645623)

Registrant - Ultra Seal Corporation (085752004)

Establishment
Name	Address	ID/FEI	Business Operations
Ultratab Laboratories, Inc.		151051757	manufacture(35418-334)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		085752004	repack(35418-334)