SINUS RELIEF HEADACHE NASAL- acetaminophen,phenylephrine hcl tablet

Sinus Relief Headache Nasal by

Drug Labeling and Warnings

Sinus Relief Headache Nasal by is a Otc medication manufactured, distributed, or labeled by Select Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

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

PURPOSE

Pain Reliever, Fever Reducer, Nasal Decongestant

DOSAGE & ADMINISTRATION

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

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 free breathing. Temporarily
relieves minor aches, pains, and fever associated with:
headache common cold toothache backache muscular
aches menstrual cramps

WARNINGS

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

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.

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

MM1

INGREDIENTS AND APPEARANCE

SINUS RELIEF HEADACHE NASAL  
acetaminophen,phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52904-493
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

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 BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	blue (sky blue)	Score	no score
Shape	ROUND (FR2)	Size	11mm
Flavor		Imprint Code	FR2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52904-493-02	2 in 1 PACKET

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)