BABY NIGHTTIME TINY COLD- chamomile, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide liquid 
Hyland's

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.

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Baby Nighttime Tiny Cold Syrup

Drug Facts

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

Uses

Temporarily relieves the symptoms of runny nose and eyes, cough, congestion, headache, sneezing and occasional sleeplessness due to common head colds in children.

Warnings

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.

Directions

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

Inactive ingredients

Citric Acid,Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

Questions or comments?

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NDC 54973-3180-1

HOMEOPATHIC

Ages

6 months+

SINCE 1903
Hyland's

Baby

Natural
Relief

Nighttime
Tiny Cold
Syrup

RELIEF OF RUNNY NOSE,
CONGESTION AND
OCCASIONAL
SLEEPLESSNESS

DUE TO COLDS*

▶ No Alcohol, Artificial Flavors,
Dyes or Parabens

4 FL. OZ. (118 mL)

1

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)

Revised: 7/2017
Document Id: 549efb5c-7383-28b8-e054-00144ff8d46c
Set id: 3806b58c-e911-4773-9eae-faaaf27d21cd
Version: 4
Effective Time: 20170718
 
Hyland's