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.

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Hyland's Naturals Kids Cold 'n Cough Combo Pack

DAYTIME

Drug Facts

Active ingredientsPurpose*
Allium Cepa 6X HPUSwatery/runny nose, cold, hacking cough, painful throat
Hepar Sulph Calc 12X HPUScold, sneezing
Hydrastis 6X HPUSrattling/tickling cough, sinus congestion, dry/raw/sore throat
Natrum Muriaticum 6X HPUSdry cough, sore throat
Phosphorus 12X HPUShoarse/dry cough, nasal congestion, chest congestion
Pulsatilla 6X HPUSmoist cough, cold, post nasal drip
Sulphur 12X HPUSchest 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 ingredientsPurpose*
Allium Cepa 6X HPUSwatery/runny nose, cold, hacking cough, painful throat
Chamomilla 6X HPUSoccasional sleeplessness
Coffea Cruda 6X HPUSoccasional sleeplessness
Hepar Sulph Calc 12X HPUScold, sneezing
Hydrastis 6X HPUSrattling/tickling cough, sinus congestion, dry/raw/sore throat
Natrum Muriaticum 6X HPUSdry cough, sore throat
Phosphorus 12X HPUShoarse/dry cough, nasal congestion, chest congestion
Pulsatilla 6X HPUSmoist cough, cold, post nasal drip
Sulphur 12X HPUSchest 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

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3378
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3378-11 in 1 CARTON; Type 0: Not a Combination Product06/08/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 118 mL
Part 21 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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE6 [hp_X]  in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3075-1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/01/2008
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA6 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3375-11 in 1 CARTON
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/08/2018
Labeler - Hyland’s Inc. (008316655)
Establishment
NameAddressID/FEIBusiness Operations
Hyland's Inc.008316655manufacture(54973-3378) , pack(54973-3378) , label(54973-3378)

Revised: 9/2023
Document Id: 065c36c9-14e6-306a-e063-6394a90af8ff
Set id: 754e8087-d825-4328-e053-2991aa0a152f
Version: 9
Effective Time: 20230927
 
Hyland’s Inc.