4 Kids Cold and Cough Nighttime: Homeopathic Product Information

4 KIDS COLD AND COUGH NIGHTTIME- onion, calcium sulfide, sodium chloride, anemone pulsatilla, matricaria chamomilla, goldenseal, arabica coffee bean, phosphorus and sulfur liquid
Hyland’s Consumer Health 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.

Temporarily relieves symptoms of cough, runny nose, post nasal drip, sneezing, sore throat, nasal or chest congestion, and occasional sleeplessness.

Drug Facts

Active ingredients

Purpose

Allium Cepa 6X HPUS

watery/runny nose, cold, hacking cough, painful throat

Chamomilla 6X HPUS

occasional sleeplessness

Coffea Cruda 6X HPUS

occasional sleeplessness

Hepar Sulph Calc 12X HPUS

cold, sneezing

Hydrastis 6X HPUS

rattling/tickling cough, sinus congestion, dry/raw/sore throat

Natrum Muriaticum 6X HPUS

dry cough, sore throat

Phosphorus 12X HPUS

hoarse/dry cough, nasal congestion, chest congestion

Pulsatilla 6X HPUS

moist cough, cold, post nasal drip

Sulphur 12X HPUS

chest congestion, nasal congestion, sneezing, runny nose

“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Uses

■ Helps temporarily relieve symptoms of common cold in children at night, including:

■ cough ■ runny nose ■ post nasal drip ■ sneezing ■ sore throat

■ nasal or chest congestion ■ occasional sleeplessness

Warnings

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache,
rash, nausea, or vomiting, consult a doctor promptly.

Ask a doctor before use if you have

■ persistent or chronic cough such as smoking, 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 7 days or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.

If pregnant or breastfeeding

Ask a health professional before use.

Keep out of reach of children.

Directions

■ Use as directed. ■ Do not refrigerate. ■ Shake well before using.

■ Measure only with dosing cup provides. ■ Do not use dosing cup with other products.

■ On dosing cup, mL = milliliter.

Children 2 years

to under 6 years

5 mL at bedtime and every 4 hours

during the night until relieved.

Children 6 years

to under 12 years

10 mL at bedtime and every 4 hours

during the night until relieved.

Adults and children

12 years and over

15 mL at bedtime and every 4 hours

during the night until relieved.

Inactive ingredients

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

Questions?

www.hylands.com or care@hylands.com

*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

Hyland’s

NATURALS™

•Kids•

Cold &

Cough*

NIGHTTIME

NO ALCOHOL, SUGAR,

PARABENS or DYES

Sleeplessness

Congestion

Runny Nose

Sore Throat

Cough

Post Nasal

Drip

2-12

YEARS

4 FL. OZ. (118 mL)

HOMEOPATHIC

Carton
(click image for full-size original)
4 KIDS COLD AND COUGH NIGHTTIME
onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3375
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ONION (ONION) ONION 6 [hp_X] in 1 mL
CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE 12 [hp_X] in 1 mL
SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 6 [hp_X] in 1 mL
ANEMONE PULSATILLA (ANEMONE PULSATILLA) ANEMONE PULSATILLA 6 [hp_X] in 1 mL
MATRICARIA CHAMOMILLA (MATRICARIA CHAMOMILLA) MATRICARIA CHAMOMILLA 6 [hp_X] in 1 mL
GOLDENSEAL (GOLDENSEAL) GOLDENSEAL 6 [hp_X] in 1 mL
ARABICA COFFEE BEAN (ARABICA COFFEE BEAN) ARABICA COFFEE BEAN 6 [hp_X] in 1 mL
PHOSPHORUS (PHOSPHORUS) PHOSPHORUS 12 [hp_X] in 1 mL
SULFUR (SULFUR) SULFUR 12 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCYRRHIZA GLABRA
GLYCERIN
CITRIC ACID MONOHYDRATE
SODIUM BENZOATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54973-3375-1 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 118 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (54973-3375-1)
2 NDC:54973-3375-2 5 mL in 1 PACKET None
3 NDC:54973-3375-3 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
3 148 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (54973-3375-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 07/01/2018
Labeler — Hyland’s Consumer Health Inc. (008316655)

Revised: 09/2022 Hyland’s Consumer Health Inc.

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