TOPCARE CHEST CONGESTION AND SINUS CONGESTION RELIEF PE- guaifenesin/phenylephrine tablet

Topcare Chest Congestion and Sinus Congestion Relief PE by

Drug Labeling and Warnings

Topcare Chest Congestion and Sinus Congestion Relief PE by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES LLC, Reese Pharmaceutical Co. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient - (per tablet)

Guaifenesin   400 mg

Phenylephrine HCl  10 mg

Purpose

Guaifenesin.......................Expectorant

Phenylephrine HCl..............Nasal decongestant

Uses

Temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies.

■ helps loosen phlegm (mucus)
■ clear nasal passageways
■ loosens nasal congestion
■ drain bronchial tubes
■ shrinks swollen membranes
■ clears stuffy nose
■ makes coughs more productive

Warnings

Do not exceed recommended dosage

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, ask a health
professional.

Ask a doctor before use if you have

■ heart disease
■ high blood pressure
■ thyroid disease
■ diabetes
■ excessive phlegm;mucus
■ difficulty in urination due to an enlarged prostate gland
■ persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema

Stop use and ask a doctor if

■ nervousness, dizziness or sleeplessness occurs
■ symptoms are accompanied by fever, rash,
persistent headache or excessive phlegm (mucus)
■ cough and congestion do not improve within 7 days
or tend to recur.
These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison
Control Center immediately.

Directions

■ adults and children 12 years and over:
take 1 caplet every 4 hours as needed
■ children 6 to under 12 years:
take 1/2 caplet every 4 hours as needed
■ children under 6 years: consult a doctor
Do not exceed 6 doses in a 24 hour period or as directed by a doctor.

Inactive ingredients

lactose, magnesium silicate,
croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin,
microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid,
titanium dioxide and triacetin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOPCARE CHEST CONGESTION AND SINUS CONGESTION RELIEF PE 
guaifenesin/phenylephrine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-989
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	400 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE (UNII: J2B2A4N98G)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POVIDONE (UNII: FZ989GH94E)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	17mm
Flavor		Imprint Code	PH043
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-989-50	1 in 1 CARTON	06/05/2006
1		50 in 1 BOTTLE; 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	06/05/2006

Labeler - TOPCO ASSOCIATES LLC (006935977)

Registrant - Reese Pharmaceutical Co (004172052)

Establishment
Name	Address	ID/FEI	Business Operations
Reese Pharmaceutical Co		004172052	relabel(36800-989) , repack(36800-989)