Baby Nighttime Tiny Cold: Homeopathic Product Information

BABY NIGHTTIME TINY COLD- matricaria recutita, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root and potassium iodide tablet
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.

Relieves nasal congestion, runny nose, sneezing, cough and occasional sleeplessness

Drug Facts

Active ingredients

Purpose

Chamomilla 6X HPUS

occasional sleeplessness

Eupatorium Perfoliatum 6X HPUS

headache, cough, sneezing

Euphrasia Officinalis 6X HPUS

runny eyes/nose, nighttime coughing

Gelsemium Sempervirens 6X HPUS

sneezing, nasal congestion,occasional sleeplessness

“HPUS” indicates that the active ingredients are in the official Homeopathic

Pharmacopoeia of the United States.

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.

Children under 6 months Ask a doctor before use.
Children 6 months
to under 1 year
At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours as needed. If symptoms persist,
2 tablets every 4 hours during the night until relieved.
Children 1 year
to under 3 years
At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours as needed. If symptoms persist,
3 tablets every 4 hours during the night until relieved.

Inactive ingredients

Acacia Gum, Lactose.

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 — 125 Tablet Bottle Carton

Hyland’s

NATURALS™

•baby•

Tiny Cold

Tablets*

Nighttime

NO ARTIFICIAL FLAVORS,

DYES or PARABENS

Sleeplessness

Nasal Congestions

Runny Nose

Sneezing

Cough

6+ MONTHS

125

QUICK-DISSOLVING TABLETS

HOMEOPATHIC

Carton
(click image for full-size original)
BABY NIGHTTIME TINY COLD
matricaria recutita, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3252
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA 6 [hp_X]
EUPATORIUM PERFOLIATUM FLOWERING TOP (EUPATORIUM PERFOLIATUM FLOWERING TOP) EUPATORIUM PERFOLIATUM FLOWERING TOP 6 [hp_X]
EUPHRASIA STRICTA (EUPHRASIA STRICTA) EUPHRASIA STRICTA 6 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT (GELSEMIUM SEMPERVIRENS ROOT) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X]
POTASSIUM IODIDE (IODIDE ION) POTASSIUM IODIDE 6 [hp_X]
Inactive Ingredients
Ingredient Name Strength
ACACIA
LACTOSE, UNSPECIFIED FORM
Product Characteristics
Color white Score no score
Shape ROUND Size 5mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54973-3252-1 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 125 TABLET in 1 BOTTLE, PLASTIC This package is contained within the CARTON (54973-3252-1)
2 NDC:54973-3252-2 6 TABLET in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 12/28/2015
Labeler — Hyland’s (028570695)
Establishment
Name Address ID/FEI Operations
Standard Homeopathic Company 008316655 manufacture (54973-3252), pack (54973-3252)
Establishment
Name Address ID/FEI Operations
Merical, Inc. 029644978 pack (54973-3252)

Revised: 11/2021 Hyland’s

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