SINUS RELIEF HEADACHE NASAL  - acetaminophen,phenylephrine hcl  tablet 
Select Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients

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



Pain Reliever, Fever Reducer, Nasal Decongestant

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

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. 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
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. • use more than the recommended dose

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 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 • 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. 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

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

KEEP OUT OF REACH OF CHILDREN.

Inactive Ingredients: corn starch, FDC Blue 1, maltodextrin,
microcrystalline cellulose, polyethylene glycol, povidone, sodium
starch glycolate, and stearic acid

MM1

Sinus Relief Headache nasal

SINUS RELIEF HEADACHE NASAL  
acetaminophen,phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-493
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
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 BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Colorblue (sky blue) Scoreno score
ShapeROUND (FR2) Size11mm
FlavorImprint Code FR2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52904-493-022 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/15/2012
Labeler - Select Corporation (053805599)

Revised: 10/2012
Document Id: ae5d9540-a988-4072-9a46-b2bfcb4fd3a1
Set id: 1d975dea-6135-4560-b62e-fa31109fd002
Version: 1
Effective Time: 20121015
 
Select Corporation