4 Kids Cold and Cough Daytime: Homeopathic Product Information

4 KIDS COLD AND COUGH DAYTIME- onion, calcium sulfide, sodium chloride, sulfur, phosphorus, anemone pulsatilla and goldenseal 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.

Drugs Facts

Active ingredients

Allium Cepa 6X HPUS

Hepar Sulph Calc 12X HPUS

Hydrastis 6X HPUS

Natrum Muriaticum 6X HPUS

Phosphorus 12X HPUS

Pulsatilla 6X HPUS

Sulphur 12X HPUS

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

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, nasal congestion

Sulphur 12X HPUS…………………………..chest congestion, nasal congestion, sneezing, runny nose

Uses

Temporarily relieves the symptoms of the common cold including: nasal or chest congestion, runny nose, sore throat, sneezing, cough.

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 high fever (101°F).
• Cough tends to recur or is accompanied by high fever, rash or persistent headache

Keep this and all medications out of the reach of children

In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

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 medical professional.

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

Sore throat warning

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly.

Do not use if imprinted tamper-evident bottle cap band is broken or missing.

The inner packaged bottle is child-resistant

In case of emergency

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 or 1 teaspoon up to 6 times per day (every 4 hours)
Children 6 years to under 12 years	10 mL or 2 teaspoons up to 6 times per day (every 4 hours)
Adults and children 12 years and over	15 mL or 3 teaspoons up to 6 times per day (every 4 hours)

Inactive ingredients

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

Questions or comments?

(800) 624-9659

Principal Display Panel — 148 mL Bottle Carton

25% MORE

BONUS PACK

NDC 54973-3400-1

HOMEOPATHIC

Ages

2-12

NATURAL

RELIEF

SINCE 1903

Hyland’s

4Kiids

Cold ‘n

Cough*

DAYTIME

Congestion

Runny Nose

Sore Throat

Sneezing

Cough

ALCOHOL FREE

SUGAR FREE

DYE FREE

4 + 1 = 5 S FL. OZ. (148 mL)

4 KIDS COLD AND COUGH DAYTIME onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3400 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 (SODIUM CATION) SODIUM CHLORIDE 6 [hp_X] in 1 mL SULFUR (SULFUR) SULFUR 12 [hp_X] in 1 mL PHOSPHORUS (PHOSPHORUS) PHOSPHORUS 12 [hp_X] in 1 mL ANEMONE PULSATILLA (ANEMONE PULSATILLA) ANEMONE PULSATILLA 6 [hp_X] in 1 mL GOLDENSEAL (GOLDENSEAL) GOLDENSEAL 6 [hp_X] in 1 mL

Inactive Ingredients Ingredient Name Strength WATER CITRIC ACID MONOHYDRATE GLYCYRRHIZA GLABRA SODIUM BENZOATE GLYCERIN

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54973-3400-1 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC 1 148 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (54973-3400-1)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/01/2008

Labeler — Hyland’s Inc. (008316655)

Establishment
Name	Address	ID/FEI	Operations
Hyland’s Inc.		008316655	manufacture (54973-3400), pack (54973-3400), label (54973-3400)

Establishment
Name	Address	ID/FEI	Operations
LGM Pharma Solutions, LLC		117549198	manufacture (54973-3400), pack (54973-3400), label (54973-3400)

Establishment
Name	Address	ID/FEI	Operations
Applied Laboratories, Inc.		117337220	manufacture (54973-3400), pack (54973-3400), label (54973-3400)

Revised: 11/2022 Hyland’s Inc.