NDC | 52904-493-02 |
Set ID | 1d975dea-6135-4560-b62e-fa31109fd002 |
Category | HUMAN OTC DRUG LABEL |
Packager | Select Corporation |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
- PURPOSE
- DOSAGE & ADMINISTRATION
-
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
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SINUS RELIEF HEADACHE NASAL
acetaminophen,phenylephrine hcl tabletProduct 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)