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

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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Hyland's Naturals Baby Tiny Cold Syrup Nighttime

Drug Facts

Drug Facts

Active ingredientsPurpose
"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Chamomilla 6X HPUSoccasional sleeplessness
Eupatorium Perfoliatum 6X HPUSheadache, cough, sneezing
Euphrasia Officinalis 6X HPUSrunny eyes and nose
Gelsemium Sempervirens 6X HPUSsneezing with stuffy nose
Kali Iodatum 6X HPUSheadache, runny eyes and nose

Uses

■ Temporarily relieves symptoms of common cold in children at night, including: ■ runny nose or eyes ■ cough ■ nasal congestion
■ headache ■ sneezing ■ occasional sleeplessness

Warnings

Ask a doctor before use if you have:

■ persistent or chronic cough such as asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious
condition. ■ cough that is accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if:

■ symptoms persist for more than 72 hours or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.

Keep out of reach of children.

Directions

■ Use as directed.  Do not refrigerate. ■ Shake well before using. ■ Measure only with the dosing syringe provided. ■ Do not use dosing syringe with other products. ■ On dosing syringe, mL = milliliter.

Children under 6 monthsAsk a doctor before use.
Children 6 months
to under 1 year
2.5 mL at bedtime and every 6 hours
during the night until relieved.
Children 1 year
to under 3 years
5 mL at bedtime and every 4 hours
during the night until relieved.

Inactive ingredients

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

Questions?

(800) 624-9659

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

DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

Hyland's

NATURALS

•baby•

Tiny Cold

Syrup

NIGHTTIME

NO ALCOHOL, SUGAR,

PARABENS or DYES

Sleeplessness

Congestion

Runny Nose

Sneezing

6+ MONTHS

4 FL. OZ. (118 mL)

HOMEOPATHIC

Carton

BABY NIGHTTIME TINY COLD 
chamomile, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3180
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE6 [hp_X]  in 1 mL
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]  in 1 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]  in 1 mL
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION6 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3180-11 in 1 CARTON07/01/2014
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:54973-3180-25 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/201412/27/2021
3NDC:54973-3180-319.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/201412/27/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/01/2014
Labeler - Hyland's Inc. (008316655)
Establishment
NameAddressID/FEIBusiness Operations
Hyland's Inc.008316655manufacture(54973-3180) , pack(54973-3180)
Establishment
NameAddressID/FEIBusiness Operations
LGM Pharma Solutions, LLC117549198manufacture(54973-3180) , pack(54973-3180) , label(54973-3180)

Revised: 11/2022
Document Id: eea4461d-3cbb-a410-e053-2995a90a5558
Set id: 3806b58c-e911-4773-9eae-faaaf27d21cd
Version: 11
Effective Time: 20221129
 
Hyland's Inc.