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
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 18, 2017
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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 runny nose and eyes, cough, congestion, headache, sneezing and occasional sleeplessness due to common head colds in children.Close
Do not use
- for persistent or chronic cough such as occurs with asthma, smoking or emphysema
- if cough is accompanied by excessive mucus, unless directed by a licensed health care professional
A persistent cough may be a sign of a serious condition.
Stop use and ask a doctor if
- symptoms persist for more than 7 days or worsen
- symptoms are accompanied by high fever (101°F)
- cough tends to recur or is accompanied by high fever, rash or persistent headache
Keep this and all medications out of reach of children. In case of accidental overdose contact a medical professional or Poison Control Center immediately.
- 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 age consult a licensed health care professional before using this product children 6 months to under 1 year of age 2.5 mL or ½ teaspoon 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 tamper band is broken or missing
- Hyland's may be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659
- Inactive ingredients
Citric Acid,Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.Close
- Questions or comments?
- 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)
- 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)