4 KIDS COMPLETE COLD AND MUCUS- bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide 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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4 Kids Daytime Cold 'n Mucus

Relieves mucus, congestion, cough, runny nose and sneezing

Drug Facts

Active ingredientsPurpose
Bryonia 6X HPUSstubborn mucus in throat, cough with yellowish mucus
Euphrasia Officinalis 6X HPUScough with mucus in chest
Hepar Sulph Calc 12X HPUScough up mucus, mucus rattle with cough, stubborn mucus in chest
Natrum Muriaticum 30X HPUSaccumulation of mucus in throat, cough up mucus
Phosphorus 30X HPUScough with expectoration of yellow mucus, chest congestion
Pulsatilla 6X HPUSaccumulation of mucus, discharge of thick yellowish mucus, loose cough
Rumex Crispus 6X HPUSrunny nose, sneezing
Silicea 12X HPUSnasal congestion

"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses

■Temporarily relieves symptoms of common cold in children, including: ■ accumulation of mucus in chest, throat or nose

■ cough with expectoration of thick, discolored mucus

■ runny nose ■ sneezing ■ nasal or chest congestion

Warnings

As with any drug, ask a doctor before use if pregnant or breast-feeding

Consult a physician if:

■ symptoms persist for more than 7 days or worsen.

■ inflammation, fever or infection develops.

■ symptoms are accompanied by a high fever (over 101°F).

■ cough tends to recur or is accompanied by a high fever, rash or persistent headache.

Keep this and all medications out of the reach of children.

Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed health care professional.

A persistent cough may be a sign of a serious condition.

In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Drug Facts (continued)

Directions

■ Measure only with the dosing cup provided

■ Do not use dosing cup with other products

■ On dosing cup, mL = milliliter, tsp = teaspoon

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).

Other information

■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

■ The inner packaged bottle is child-resistant.

■ Store at room temperature.

■ Do not refrigerate.

Inactive ingredients

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

Questions or comments?

(800) 624-9659

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

HOMEOPATHIC

NDC 54973-3179-1


2-12

YEARS

New
Look

4 Kids

SINCE 1903
Hyland's®

DAYTIME

Cold &
Mucus
*

Relieves mucus,

congestion, cough,

runny nose and sneezing

NO ALCOHOL or PARABENS

NO SUGAR or DYES

NATURAL

RELIEF

4 FL. OZ. (118 mL)

*SEE NOTE

ON SIDE PANEL

BELOW DRUG FACTS

carton

4 KIDS COMPLETE COLD AND MUCUS 
bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3179
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 1 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE30 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS30 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT6 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3179-11 in 1 CARTON07/01/2014
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:54973-3179-21 in 1 CARTON10/17/201412/15/2021
219.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:54973-3179-410 in 1 CARTON07/01/201412/15/2021
35 mL in 1 POUCH; Type 0: Not a Combination Product
4NDC:54973-3179-51 in 1 CARTON07/01/2014
4148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/01/2014
Labeler - Hyland's Inc. (008316655)
Establishment
NameAddressID/FEIBusiness Operations
Hyland's Inc.008316655manufacture(54973-3179) , pack(54973-3179) , label(54973-3179)
Establishment
NameAddressID/FEIBusiness Operations
Applied Laboratories, Inc.117337220pack(54973-3179)
Establishment
NameAddressID/FEIBusiness Operations
LGM Pharma Solutions, LLC117549198manufacture(54973-3179) , pack(54973-3179) , label(54973-3179)

Revised: 11/2022
Document Id: edfe5da0-ee7f-30c2-e053-2995a90ae175
Set id: ef39fe3d-a42d-4baa-9199-91f664feb432
Version: 11
Effective Time: 20221121
 
Hyland's Inc.