SINUS RELIEF SEVERE CONGESTION- acetaminophen,guaifenesin, phenylephrine hcl tablet

Sinus Relief Severe Congestion by

Drug Labeling and Warnings

Sinus Relief Severe Congestion by is a Otc medication manufactured, distributed, or labeled by Select Corporation, ULTRAtab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                              Purpose

Acetaminophen 325 mg.......................Pain Reliever/Fever Reducer
Guaifenesin 200 mg.............................Expectorant
Phenylephrine HCl 5 mg.............................Nasal Decongestant

PURPOSE

Pain Reliever, Fever Reducer, Expectorant, Nasal Decongestant

DOSAGE

Directions: Adults and children 12
years and over: take 2 tablets every 4 to 6 hours as needed, do
not exceed more than 8 tablets in 24 hours,or as directed by a
doctor Children under 12 years: consult a doctor

INDICATIONS

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 free breathing
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive

Temporarily relieves minor aches, pains, and fever associated with:

headache

common cold

toothache

backache

muscular aches

menstrual cramps

WARNINGS

 Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 tablets in 24 hours with other drugs containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. 3 or more alcoholic drinks every day while using this product A persistent cough may be a sign of a serious condition

Do not: use with any other product containing acetaminophen this will provide more than the recommended
dose (overdose) of acetaminophen and could cause serious health concerns. 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. for more
than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a
doctor when using this product do not exceed the recommended dose. Ask a doctor before use if you
have: heart disease high blood pressure thyroid disease diabetes difficulty in urinating due to an enlarged
prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where
cough is accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if: symptoms do not improve pain or fever persists or gets worse 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 cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache

PREGNANCY

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

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

INACTIVE INGREDIENT

Inactive ingredients: FDC Red 40,
Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch
Glycolate, Starch, Stearic Acid

PRINCIPAL DISPLAY PANEL

MM1

INGREDIENTS AND APPEARANCE

SINUS RELIEF SEVERE CONGESTION  
acetaminophen,guaifenesin, phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52904-455
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)
STEARIC ACID (UNII: 4ELV7Z65AP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Product Characteristics
Color	pink (blossom pink)	Score	no score
Shape	ROUND (FR14)	Size	12mm
Flavor		Imprint Code	FR14
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52904-455-50	25 in 1 BOX	10/15/2012
1	NDC: 52904-455-06	1 in 1 CARTON
1	NDC: 52904-455-02	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	10/15/2012

Labeler - Select Corporation (053805599)

Establishment
Name	Address	ID/FEI	Business Operations
Select Corporation		053805599	label(52904-455)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab Laboratories, Inc.		151051757	manufacture(52904-455)