{"active_ingredient":["ACTIVE INGREDIENT-ACETAMINOPHEN 500 MG, PHENYLEPHRINE HCl 5 MG"],"dosage_and_administration":["Directions: Adults and children 12 years of age and older take 2 tablets every 4-6 hours, as needed, not to exceed 8 tablets in 24 hrs as directed by a doctor. Children under 12 years Consult a doctor."],"effective_time":"20230106","id":"f19ab189-e0ed-307d-e053-2995a90a3723","inactive_ingredient":["Inactive Ingredients: FD&C Blue #1, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Starch, Stearic Acid"],"indications_and_usage":["UseS TEMPORARILY • relieves nasal congestion associated with sinusitis • relieves nasal congestion due to the common cold, hay fever or other 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"],"keep_out_of_reach_of_children":["KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["SINU-PHED PLUS BOX"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["PAIN RELIEVER, FEVER REDUCER, NASAL DECONGESTANT"],"set_id":"73b3b4ed-6aaf-4f7b-8dee-2b7221aa7174","spl_product_data_elements":["Sinu-Phen Plus Phenylephrine HCl, Acetaminophen CROSCARMELLOSE SODIUM SODIUM STARCH GLYCOLATE TYPE A CORN FD&C BLUE NO. 1 STEARIC ACID CELLULOSE, MICROCRYSTALLINE POVIDONE K30 STARCH, PREGELATINIZED CORN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACETAMINOPHEN ACETAMINOPHEN SKY BLUE FR2"],"version":"3","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 aceteminophen 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 Parkingson’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"]}