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 common head colds in children, including: runny nose or eyes, cough, congestion, headache, sneezing,occasional sleeplessness

Warnings

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.

Keep this and all medications out of reach of children.

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.

A persistent cough may be a sign of a serious condition.

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

Directions

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

Inactive ingredients

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

Questions or comments?

(800) 624-9659

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NDC 54973-3180-1
HOMEOPATHIC

Ages

6 months+

Natural
Relief

SINCE 1903
Hyland's

Baby

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)

*SEE NOTE ON BACK PANEL BELOW DRUG FACTS

Carton

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: 7/2019
Document Id: 8ca064b0-4c98-d927-e053-2a95a90af75e
Set id: 3806b58c-e911-4773-9eae-faaaf27d21cd
Version: 5
Effective Time: 20190701
 
Hyland's