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

Baby Nighttime Tiny Cold by

Drug Labeling and Warnings

Baby Nighttime Tiny Cold by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc., LGM Pharma Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

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

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

• 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.

Questions or comments?

(800) 624-9659

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*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

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)