{ "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": "2026-07-18", "results": { "skip": 0, "limit": 1, "total": 80 } }, "results": [ { "spl_product_data_elements": [ "4 Kids Cold and Cough Day and Night Grape Flavor onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean 4 KIDS COLD N COUGH GRAPE FLAVOR onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur SODIUM BENZOATE CITRIC ACID MONOHYDRATE GLYCERIN GLYCYRRHIZA GLABRA WATER ONION ONION GOLDENSEAL GOLDENSEAL CALCIUM SULFIDE CALCIUM SULFIDE SODIUM CHLORIDE SODIUM CATION PHOSPHORUS PHOSPHORUS ANEMONE PULSATILLA ANEMONE PULSATILLA SULFUR SULFUR 4 KIDS COLD AND COUGH NIGHTTIME NATURAL GRAPE FLAVOR onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean CITRIC ACID MONOHYDRATE GLYCERIN WATER GLYCYRRHIZA GLABRA SODIUM BENZOATE ANEMONE PULSATILLA ANEMONE PULSATILLA SULFUR SULFUR CALCIUM SULFIDE CALCIUM SULFIDE GOLDENSEAL GOLDENSEAL SODIUM CHLORIDE CHLORIDE ION MATRICARIA CHAMOMILLA MATRICARIA CHAMOMILLA ARABICA COFFEE BEAN ARABICA COFFEE BEAN ONION ONION PHOSPHORUS PHOSPHORUS" ], "purpose": [ "Relieves congestion, runny nose, sore throat, sneezing, cough, post nasal drip and occasional sleeplessness" ], "spl_unclassified_section": [ "DAYTIME Drug Facts Active ingredients Purpose Allium Cepa 6X HPUS watery/runny nose, cold, hacking cough, painful throat Hepar Sulph Calc 12X HPUS cold, sneezing Hydrastis 6X HPUS rattling/tickling cough, sinus congestion, dry/raw/sore throat Natrum Muriaticum 6X HPUS dry cough, sore throat Phosphorus 12X HPUS hoarse/dry cough, nasal congestion, chest congestion Pulsatilla 6X HPUS moist cough, cold, post nasal drip Sulphur 12X HPUS chest congestion, nasal congestion, sneezing, runny nose \"HPUS\" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States. Uses ■ Temporarily relieves symptoms of common cold in children, including: ■ runny nose ■ sore throat ■ sneezing ■ cough ■ post nasal drip ■ nasal or chest congestion Warnings Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Ask a doctor before use if you have: ■ persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus). Stop use and ask a doctor if: ■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. Directions ■ Use as directed. ■ Do not refrigerate. ■ Shake well before using. ■ Measure only with the dosing cup provided. ■ Do not use dosing cup with other products. ■ On dosing cup, mL = milliliter. Children 2 years to under 6 years 5 mL up to 6 times per day (every 4 hours). Children 6 years to under 12 years 10 mL up to 6 times per day (every 4 hours). Adults and children 12 years and over 15 mL up to 6 times per day (every 4 hours). Inactive ingredients Citric Acid, Glycerine, Glycyrrhiza Extract, Natural Grape Flavor, Purified Water, Sodium Benzoate.", "NIGHTTIME Drug Facts Active ingredients Purpose Allium Cepa 6X HPUS watery/runny nose, cold, hacking cough, painful throat Chamomilla 6X HPUS occasional sleeplessness Coffea Cruda 6X HPUS occasional sleeplessness Hepar Sulph Calc 12X HPUS cold, sneezing Hydrastis 6X HPUS rattling/tickling cough, sinus congestion, dry/raw/sore throat Natrum Muriaticum 6X HPUS dry cough, sore throat Phosphorus 12X HPUS hoarse/dry cough, nasal congestion, chest congestion Pulsatilla 6X HPUS moist cough, cold, post nasal drip Sulphur 12X HPUS chest congestion, nasal congestion, sneezing, runny nose HPUS\" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States. Uses ■ Temporarily relieves symptoms of common cold in children at night, including: ■ cough ■ runny nose ■ post nasal drip ■ sneezing ■ nasal or chest congestion ■ sore throat ■ occasional sleeplessness Warnings Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Ask a doctor before use if you have: ■ persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus). Stop use and ask a doctor if: ■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. Directions ■ Use as directed. ■ Do not refrigerate. ■ Shake well before using. ■ Measure only with the dosing cup provided. ■ Do not use dosing cup with other products. ■ On dosing cup, mL = milliliter. Children 2 years to under 6 years 5 mL at bedtime and every 4 hours during the night until relieved. Children 6 years to under 12 years 10 mL at bedtime and every 4 hours during the night until relieved. Adults and children 12 years and over 15 mL at bedtime and every 4 hours during the night until relieved. Inactive ingredients Citric Acid, Glycerine, Glycyrrhiza Extract, Natural Grape Flavor, Purified Water, Sodium Benzoate. Questions? (800) 624-9659", "*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED." ], "spl_unclassified_section_table": [ "
Active ingredientsPurpose
Allium Cepa 6X HPUSwatery/runny nose, cold, hacking cough, painful throat
Hepar Sulph Calc 12X HPUScold, sneezing
Hydrastis 6X HPUSrattling/tickling cough, sinus congestion, dry/raw/sore throat
Natrum Muriaticum 6X HPUSdry cough, sore throat
Phosphorus 12X HPUShoarse/dry cough, nasal congestion, chest congestion
Pulsatilla 6X HPUSmoist cough, cold, post nasal drip
Sulphur 12X HPUSchest congestion, nasal congestion, sneezing, runny nose
", "
Children 2 years to under 6 years 5 mL up to 6 times per day (every 4 hours).
Children 6 years to under 12 years 10 mL up to 6 times per day (every 4 hours).
Adults and children 12 years and over 15 mL up to 6 times per day (every 4 hours).
", "
Active ingredientsPurpose
Allium Cepa 6X HPUSwatery/runny nose, cold, hacking cough, painful throat
Chamomilla 6X HPUSoccasional sleeplessness
Coffea Cruda 6X HPUSoccasional sleeplessness
Hepar Sulph Calc 12X HPUScold, sneezing
Hydrastis 6X HPUSrattling/tickling cough, sinus congestion, dry/raw/sore throat
Natrum Muriaticum 6X HPUSdry cough, sore throat
Phosphorus 12X HPUShoarse/dry cough, nasal congestion, chest congestion
Pulsatilla 6X HPUSmoist cough, cold, post nasal drip
Sulphur 12X HPUSchest congestion, nasal congestion, sneezing, runny nose
", "
Children 2 years to under 6 years 5 mL at bedtime and every 4 hours during the night until relieved.
Children 6 years to under 12 years 10 mL at bedtime and every 4 hours during the night until relieved.
Adults and children 12 years and over 15 mL at bedtime and every 4 hours during the night until relieved.
" ], "active_ingredient": [ "Active ingredients Purpose Allium Cepa 6X HPUS watery/runny nose, cold, hacking cough, painful throat Hepar Sulph Calc 12X HPUS cold, sneezing Hydrastis 6X HPUS rattling/tickling cough, sinus congestion, dry/raw/sore throat Natrum Muriaticum 6X HPUS dry cough, sore throat Phosphorus 12X HPUS hoarse/dry cough, nasal congestion, chest congestion Pulsatilla 6X HPUS moist cough, cold, post nasal drip Sulphur 12X HPUS chest congestion, nasal congestion, sneezing, runny nose \"HPUS\" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.", "Active ingredients Purpose Allium Cepa 6X HPUS watery/runny nose, cold, hacking cough, painful throat Chamomilla 6X HPUS occasional sleeplessness Coffea Cruda 6X HPUS occasional sleeplessness Hepar Sulph Calc 12X HPUS cold, sneezing Hydrastis 6X HPUS rattling/tickling cough, sinus congestion, dry/raw/sore throat Natrum Muriaticum 6X HPUS dry cough, sore throat Phosphorus 12X HPUS hoarse/dry cough, nasal congestion, chest congestion Pulsatilla 6X HPUS moist cough, cold, post nasal drip Sulphur 12X HPUS chest congestion, nasal congestion, sneezing, runny nose HPUS\" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States." ], "active_ingredient_table": [ "
Active ingredientsPurpose
Allium Cepa 6X HPUSwatery/runny nose, cold, hacking cough, painful throat
Hepar Sulph Calc 12X HPUScold, sneezing
Hydrastis 6X HPUSrattling/tickling cough, sinus congestion, dry/raw/sore throat
Natrum Muriaticum 6X HPUSdry cough, sore throat
Phosphorus 12X HPUShoarse/dry cough, nasal congestion, chest congestion
Pulsatilla 6X HPUSmoist cough, cold, post nasal drip
Sulphur 12X HPUSchest congestion, nasal congestion, sneezing, runny nose
", "
Active ingredientsPurpose
Allium Cepa 6X HPUSwatery/runny nose, cold, hacking cough, painful throat
Chamomilla 6X HPUSoccasional sleeplessness
Coffea Cruda 6X HPUSoccasional sleeplessness
Hepar Sulph Calc 12X HPUScold, sneezing
Hydrastis 6X HPUSrattling/tickling cough, sinus congestion, dry/raw/sore throat
Natrum Muriaticum 6X HPUSdry cough, sore throat
Phosphorus 12X HPUShoarse/dry cough, nasal congestion, chest congestion
Pulsatilla 6X HPUSmoist cough, cold, post nasal drip
Sulphur 12X HPUSchest congestion, nasal congestion, sneezing, runny nose
" ], "indications_and_usage": [ "Uses ■ Temporarily relieves symptoms of common cold in children, including: ■ runny nose ■ sore throat ■ sneezing ■ cough ■ post nasal drip ■ nasal or chest congestion", "Uses ■ Temporarily relieves symptoms of common cold in children at night, including: ■ cough ■ runny nose ■ post nasal drip ■ sneezing ■ nasal or chest congestion ■ sore throat ■ occasional sleeplessness" ], "warnings": [ "Warnings Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Ask a doctor before use if you have: ■ persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus). Stop use and ask a doctor if: ■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children.", "Warnings Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Ask a doctor before use if you have: ■ persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus). Stop use and ask a doctor if: ■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children." ], "ask_doctor": [ "Ask a doctor before use if you have: ■ persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).", "Ask a doctor before use if you have: ■ persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus)." ], "stop_use": [ "Stop use and ask a doctor if: ■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.", "Stop use and ask a doctor if: ■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache." ], "pregnancy_or_breast_feeding": [ "If pregnant or breastfeeding, ask a health professional before use.", "If pregnant or breastfeeding, ask a health professional before use." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children.", "Keep out of reach of children." ], "dosage_and_administration": [ "Directions ■ Use as directed. ■ Do not refrigerate. ■ Shake well before using. ■ Measure only with the dosing cup provided. ■ Do not use dosing cup with other products. ■ On dosing cup, mL = milliliter. Children 2 years to under 6 years 5 mL up to 6 times per day (every 4 hours). Children 6 years to under 12 years 10 mL up to 6 times per day (every 4 hours). Adults and children 12 years and over 15 mL up to 6 times per day (every 4 hours).", "Directions ■ Use as directed. ■ Do not refrigerate. ■ Shake well before using. ■ Measure only with the dosing cup provided. ■ Do not use dosing cup with other products. ■ On dosing cup, mL = milliliter. Children 2 years to under 6 years 5 mL at bedtime and every 4 hours during the night until relieved. Children 6 years to under 12 years 10 mL at bedtime and every 4 hours during the night until relieved. Adults and children 12 years and over 15 mL at bedtime and every 4 hours during the night until relieved." ], "dosage_and_administration_table": [ "
Children 2 years to under 6 years 5 mL up to 6 times per day (every 4 hours).
Children 6 years to under 12 years 10 mL up to 6 times per day (every 4 hours).
Adults and children 12 years and over 15 mL up to 6 times per day (every 4 hours).
", "
Children 2 years to under 6 years 5 mL at bedtime and every 4 hours during the night until relieved.
Children 6 years to under 12 years 10 mL at bedtime and every 4 hours during the night until relieved.
Adults and children 12 years and over 15 mL at bedtime and every 4 hours during the night until relieved.
" ], "inactive_ingredient": [ "Inactive ingredients Citric Acid, Glycerine, Glycyrrhiza Extract, Natural Grape Flavor, Purified Water, Sodium Benzoate.", "Inactive ingredients Citric Acid, Glycerine, Glycyrrhiza Extract, Natural Grape Flavor, Purified Water, Sodium Benzoate." ], "questions": [ "Questions? (800) 624-9659" ], "other_safety_information": [ "DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING." ], "recent_major_changes": [ "Indications and Usage update: Uses Temporarily relieves symptoms of common cold in children, including: runny nose  sore throat sneezing cough  post nasal drip nasal or chest congestion", "Dosage and Administration Directions 5 mL up to 6 times per day (every 4 hours) 10 mL up to 6 times per day (every 4 hours) 15 mL up to 6 times per day (every 4 hours)" ], "package_label_principal_display_panel": [ "PACKAGE LABEL - KIT CARTON Hyland's •KIDS• Cold & Cough COMBO PACK NO ALCOHOL, SUGAR, PARABENS or DYES DAYTIME Congestion Runny Nose Sore Throat Cough Post Nasal Drip NIGHTTIME Sleeplessness Congestion Runny Nose Sore Throat Cough Post Nasal Drip 2-12 YEARS NATURAL GRAPE FLAVOR TWO - 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night) | TOTAL 8 FL. OZ. (236 ML) HOMEOPATHIC CCKDNFLF13PK" ], "set_id": "1a297e56-4cb8-75ca-e063-6294a90a592b", "id": "2e9c98ee-55a2-431e-e063-6294a90a09c1", "effective_time": "20250220", "version": "3", "openfda": { "brand_name": [ "4 Kids Cold and Cough Day and Night Grape Flavor" ], "generic_name": [ "ONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEAN" ], "manufacturer_name": [ "Hyland's Inc." ], "product_ndc": [ "54973-4127" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "spl_id": [ "2e9c98ee-55a2-431e-e063-6294a90a09c1" ], "spl_set_id": [ "1a297e56-4cb8-75ca-e063-6294a90a592b" ], "package_ndc": [ "54973-4127-1", "54973-3243-1", "54973-3377-1" ], "is_original_packager": [ true ] } } ] }