DECONGESTANT II- phenylephrine hcl tablet

DECONGESTANT II by

Drug Labeling and Warnings

DECONGESTANT II by is a Otc medication manufactured, distributed, or labeled by ADVANCED FIRST AID, INC., ULTRA SEAL CORPORATION, ULTRA TAB LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT (IN EACH TABLET)- Phenylephrine HCl 5 mg

PURPOSE

Nasal Decongestant

INDICATIONS & USAGE

Uses: temporarily: relieves nasal congestion associated with sinusitis relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies relieves sinus congestion and pressure, helps decongest sinus openings and passages restores freer breathing through the nose

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.

DOSAGE & ADMINISTRATION

Directions:

Adults and children 12 years of age and older:  Take 2 tablets every 4 to 6 hours or as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor.

Children under 12 years: Consult a doctor.

INACTIVE INGREDIENT

Inactive Ingredients: crosscarmellose sodium, D&C Red #27 lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, stearic acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DECONGESTANT II 
phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67060-333
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	FR4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67060-333-68	100 in 1 CARTON	04/09/2015
1	NDC: 67060-333-02	2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 67060-333-67	250 in 1 CARTON	04/09/2015
2	NDC: 67060-333-02	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	04/09/2015

Labeler - ADVANCED FIRST AID, INC. (114477180)

Registrant - ADVANCED FIRST AID, INC. (114477180)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA SEAL CORPORATION		085752004	pack(67060-333)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA TAB LABORATORIES, INC.		151051757	manufacture(67060-333)