Label: BABY NIGHTTIME TINY COLD- chamomile, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide liquid
- NDC Code(s): 54973-3180-1, 54973-3180-2, 54973-3180-3
- Packager: Hyland's
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Updated July 1, 2019
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredients Purpose "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States. Chamomilla 6X HPUS occasional sleeplessness Eupatorium Perfoliatum 6X HPUS headache, cough, sneezing Euphrasia Officinalis 6X HPUS runny eyes and nose Gelsemium Sempervirens 6X HPUS sneezing with stuffy nose Kali Iodatum 6X HPUS headache, runny eyes and nose
Temporarily relieves the symptoms of common head colds in children, including: runny nose or eyes, cough, congestion, headache, sneezing,occasional sleeplessnessClose
Consult a physician if: • symptoms persist for more 7 days or worsen. • inflammation, fever or infection develops. • symptoms are accompanied by a high fever (over 101°F). • cough tends to recur or is accompanied by a high fever, rash or persistent headache.
Do Not use this product for persistent or chronic cough such as asthma, smoking, emphysema or if cough is accompanied by excessive mucus, unless directed by a medical professional.
In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland's may also be contacted for emergency information about our products 24 houra a day, 7 days per week at (800) 624-9659
- Measure only with the dosing syringe provided
- Do not use dosing syringe with other products
- On dosing syringe, mL = milliliter, tsp = teaspoon
children under 6 months of agev consult a physician before using this product children 6 months to under 1 year of age 2.5 mL up to 4 times daily (every 6 hours) children 1 to 3 years of age 5 mL or 1 teaspoon up to 6 times daily (every 4 hours)
- Other information
- Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
- The inner packaged bottle is child-resistant.
- Store at room temperature.
- Do not refrigerate.
- Inactive ingredients
Citric Acid,Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.Close
- Questions or comments?
- SPL UNCLASSIFIED SECTION
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
RELIEF OF RUNNY NOSE,
DUE TO COLDS*
▶ No Alcohol, Artificial Flavors,
Dyes or Parabens
4 FL. OZ. (118 mL)
*SEE NOTE ON BACK PANEL BELOW DRUG FACTS
- INGREDIENTS AND APPEARANCE
BABY NIGHTTIME TINY COLD
chamomile, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3180 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE 6 [hp_X] in 1 mL EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 6 [hp_X] in 1 mL EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 6 [hp_X] in 1 mL GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X] in 1 mL POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 6 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3180-1 1 in 1 CARTON 07/01/2014 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:54973-3180-2 5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2014 3 NDC:54973-3180-3 19.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/01/2014 Labeler - Hyland's (028570695) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 008316655 manufacture(54973-3180) , pack(54973-3180) Establishment Name Address ID/FEI Business Operations NEXGEN PHARMA, INC. 079424083 manufacture(54973-3180) , pack(54973-3180)