Label: SINUS RELIEF HEADACHE NASAL- acetaminophen,phenylephrine hcl tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 52904-493-02 - Packager: Select Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated October 15, 2012
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- DOSAGE & ADMINISTRATION
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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
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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
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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)
