4 Kids Cold and Cough Daytime and Nighttime: Homeopathic Product Information

4 KIDS COLD AND COUGH DAYTIME AND NIGHTTIME- onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal
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.

DAYTIME

Drug Facts

Active ingredients Purpose*
Allium Cepa 6X HPUS watery/runny nose, cold, hacking cough, painful throat
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” is the Homeopathic Pharmacopoeia of the United States.

Uses*

■ Helps temporarily relieve symptoms of common cold in children, including:
■ runny nose ■ sore throat ■ sneezing ■ cough
■ post nasal drip ■ nasal or chest congestion

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 the dosing cup provided. ■ Do not use
dosing cup with other products. ■ On dosing cup, mL = milliliter.

Children 2 years
to under 6 years
5 mL up to 6 times per day (every 4 hours).
Children 6 years
to under 12 years
10 mL up to 6 times per day (every 4 hours).
Adults and children
12 years and over
15 mL up to 6 times per day (every 4 hours).

Inactive ingredients

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

NIGHTTIME

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” is the 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 the dosing cup provided. ■ 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.

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.

Principal Display Panel — Kids Cold & Cough Daytime Nighttime Combo Pack

Hyland’s

NATURALS™

•baby•

Cold & Cough*

COMBO BACK

NO ALCOHOL, SUGAR, PARABENS or DYES

DAYTIME

Congestion*

Runny Nose*

Sore Throat*

Cough*

Post Nasal

Drip*

NIGHTTIME

Sleeplessness*

Congestion*

Runny Nose*

Sore Throat*

Cough*

Post Nasal

Drip*

2 — 12 YEARS

TWP — 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night)

HOMEOPATHIC

carton
(click image for full-size original)
4 KIDS COLD AND COUGH DAYTIME AND NIGHTTIME
onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3378
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54973-3378-1 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE, PLASTIC 118 mL
Part 2 1 BOTTLE, PLASTIC 118 mL
Part 1 of 2
COLD AND COUGH 4 KIDS
onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid
Product Information
Item Code (Source) NDC:54973-3075
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 6 [hp_X] in 1 mL
ONION (ONION) ONION 6 [hp_X] in 1 mL
CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE 12 [hp_X] in 1 mL
PHOSPHORUS (PHOSPHORUS) PHOSPHORUS 12 [hp_X] in 1 mL
SULFUR (SULFUR) SULFUR 12 [hp_X] in 1 mL
GOLDENSEAL (GOLDENSEAL) GOLDENSEAL 6 [hp_X] in 1 mL
ANEMONE PULSATILLA (ANEMONE PULSATILLA) ANEMONE PULSATILLA 6 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
CITRIC ACID MONOHYDRATE
SODIUM BENZOATE
GLYCYRRHIZA GLABRA
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54973-3075-1 118 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 08/01/2008
Part 2 of 2
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
Item Code (Source) NDC:54973-3375
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARABICA COFFEE BEAN (ARABICA COFFEE BEAN) ARABICA COFFEE BEAN 6 [hp_X] in 1 mL
ONION (ONION) ONION 6 [hp_X] in 1 mL
CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE 12 [hp_X] in 1 mL
PHOSPHORUS (PHOSPHORUS) PHOSPHORUS 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
SULFUR (SULFUR) SULFUR 12 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCYRRHIZA GLABRA
GLYCERIN
CITRIC ACID MONOHYDRATE
SODIUM BENZOATE
WATER
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)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 07/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 06/08/2018
Labeler — Hyland’s Inc. (008316655)
Establishment
Name Address ID/FEI Operations
Hyland’s Inc. 008316655 manufacture (54973-3378), pack (54973-3378), label (54973-3378)

Revised: 09/2023 Hyland’s Inc.

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