4 Kids Complete Cold and Mucus: Homeopathic Product Information

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

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 mucus, congestion, cough, runny nose and sneezing

Drug Facts

Active ingredients Purpose
Bryonia 6X HPUS stubborn mucus in throat, cough with yellowish mucus
Euphrasia Officinalis 6X HPUS cough with mucus in chest
Hepar Sulph Calc 12X HPUS cough up mucus, mucus rattle with cough, stubborn mucus in chest
Natrum Muriaticum 30X HPUS accumulation of mucus in throat, cough up mucus
Phosphorus 30X HPUS cough with expectoration of yellow mucus, chest congestion
Pulsatilla 6X HPUS accumulation of mucus, discharge of thick yellowish mucus, loose cough
Rumex Crispus 6X HPUS runny nose, sneezing
Silicea 12X HPUS nasal 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
(click image for full-size original)
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 Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3179
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT 6 [hp_X] in 1 mL
EUPHRASIA STRICTA (EUPHRASIA STRICTA) EUPHRASIA STRICTA 6 [hp_X] in 1 mL
CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE 12 [hp_X] in 1 mL
SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 30 [hp_X] in 1 mL
PHOSPHORUS (PHOSPHORUS) PHOSPHORUS 30 [hp_X] in 1 mL
ANEMONE PULSATILLA (ANEMONE PULSATILLA) ANEMONE PULSATILLA 6 [hp_X] in 1 mL
RUMEX CRISPUS ROOT (RUMEX CRISPUS ROOT) RUMEX CRISPUS ROOT 6 [hp_X] in 1 mL
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE 12 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCYRRHIZA GLABRA
WATER
SODIUM BENZOATE
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54973-3179-1 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 118 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (54973-3179-1)
2 NDC:54973-3179-2 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
2 19.8 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (54973-3179-2)
3 NDC:54973-3179-4 10 POUCH in 1 CARTON contains a POUCH
3 5 mL in 1 POUCH This package is contained within the CARTON (54973-3179-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 07/01/2014
Labeler — Hyland’s (028570695)
Establishment
Name Address ID/FEI Operations
Standard Homeopathic Company 008316655 manufacture (54973-3179), pack (54973-3179)
Establishment
Name Address ID/FEI Operations
Nexgen Pharma, Inc. 079424083 manufacture (54973-3179), pack (54973-3179)
Establishment
Name Address ID/FEI Operations
Applied Laboratories, Inc. 117337220 pack (54973-3179)

Revised: 08/2020 Hyland’s

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