{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-06-10",
    "results": {
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      "total": 8
    }
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  "results": [
    {
      "spl_product_data_elements": [
        "Daytime Nighttime Sinus Relief Acetaminophen, Diphenhydramine HCl, Guaifenesin, Phenylephrine HCl Daytime Sinus Relief Acetaminophen, Guaifenesin, Phenylephrine HCl CROSCARMELLOSE SODIUM SILICON DIOXIDE ACETAMINOPHEN ACETAMINOPHEN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CROSPOVIDONE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED GUAIFENESIN GUAIFENESIN Light Orange to Orange 153 capsule shaped Nighttime Sinus Relief Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED SILICON DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Light Blue to Blue color 154 Capsule shaped"
      ],
      "active_ingredient": [
        "Active ingredients (in each caplet) (Sinus Day) Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg",
        "Active ingredients (in each caplet) (Sinus Night) Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg Phenylephrine HCl 5 mg"
      ],
      "purpose": [
        "Purpose Pain reliever Expectorant Nasal decongestant",
        "Purpose Pain reliever Antihistamine/cough suppressant Nasal decongestant"
      ],
      "indications_and_usage": [
        "Uses temporarily relieves these common cold symptoms: nasal congestion headache minor aches and pains sinus congestion and pressure cough (Nighttime only) runny nose and sneezing (Nighttime only) temporarily promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Daytime only)"
      ],
      "warnings": [
        "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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 the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients with any other product containing diphenhydramine, even one used on skin (Nighttime only) Ask a doctor before use if you have heart disease liver disease diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis (Nighttime only) glaucoma (Nighttime only) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (Nighttime only) When using this product do not exceed recommended dosage excitability may occur, especially in children (Nighttime only) marked drowsiness may occur (Nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only) avoid alcoholic beverages (Nighttime only) use caution when driving a motor vehicle or operating machinery (Nighttime only) Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not take DAYTIME and NIGHTTIME products at the same time."
      ],
      "do_not_use": [
        "Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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 the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients with any other product containing diphenhydramine, even one used on skin (Nighttime only)"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have heart disease liver disease diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis (Nighttime only) glaucoma (Nighttime only)"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (Nighttime only)"
      ],
      "when_using": [
        "When using this product do not exceed recommended dosage excitability may occur, especially in children (Nighttime only) marked drowsiness may occur (Nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only) avoid alcoholic beverages (Nighttime only) use caution when driving a motor vehicle or operating machinery (Nighttime only)"
      ],
      "stop_use": [
        "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition."
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding, ask a health professional before use."
      ],
      "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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Do not take DAYTIME and NIGHTTIME products at the same time."
      ],
      "dosage_and_administration": [
        "Directions do not take more than directed do not take more than 12 caplets in any 24-hour period adults and children 12 years and over: take 2 caplets every 4 hours children under 12 years: do not use"
      ],
      "storage_and_handling": [
        "Other information Other information store at 25°C(77°F), excursion permitted between 15-30°C (59-86°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients (Daytime only) Inactive ingredients (Sinus Day only) colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C red no. 40, FD&C yellow no. 6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide",
        "Inactive ingredients (Nighttime only) Inactive ingredients (Sinus Night only) colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 1, FD&C blue no. 2 magnesium stearate, methacrylic acid, mica, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide"
      ],
      "questions": [
        "Questions or comments? Call 1-800-910-6874"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel 788R_Target_IFC"
      ],
      "set_id": "23f50b88-52c3-2029-e063-6394a90ac73e",
      "id": "37855521-b5e0-2809-e063-6294a90ad515",
      "effective_time": "20250614",
      "version": "3",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Daytime Nighttime Sinus Relief"
        ],
        "generic_name": [
          "ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL"
        ],
        "manufacturer_name": [
          "Target Corporation"
        ],
        "product_ndc": [
          "11673-530"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "rxcui": [
          "1233575",
          "1243679",
          "2634398"
        ],
        "spl_id": [
          "37855521-b5e0-2809-e063-6294a90ad515"
        ],
        "spl_set_id": [
          "23f50b88-52c3-2029-e063-6394a90ac73e"
        ],
        "package_ndc": [
          "11673-530-02"
        ],
        "is_original_packager": [
          true
        ]
      }
    }
  ]
}