4 KIDS COLD N COUGH GRAPE FLAVOR: Homeopathic Product Information

4 KIDS COLD N COUGH GRAPE FLAVOR- onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla and sulfur 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.

Relieves congestion, runny nose, sore throat, sneezing, cough and post nasal drip

Drug Facts

Active ingredients

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 Pharmacopœia 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, Natural Grape Flavor, 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.

Principal Display Panel — 4 FL. OZ. (118 mL)

Hyland’s

NATURALS™

Kids

Cold &

Cough*

DAYTIME

NO ALCOHOL, SUGAR,

PARABENS or DYES

Congestion*

Runny Nose*

Sore Throat*

Cough*

Post Nasal

Drip*

2 — 12

YEARS

4 FL. OZ. (118 mL)

HOMEOPATHIC

carton.
(click image for full-size original)

Principal Display Panel — 5 FL. OZ. (148 mL)

NDC 54973-3243-4 5 FL. OZ.

carton
(click image for full-size original)
label
(click image for full-size original)

4 KIDS COLD N COUGH GRAPE FLAVOR
onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3243
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
GOLDENSEAL (GOLDENSEAL) GOLDENSEAL 6 [hp_X] in 1 mL
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 6 [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
SULFUR (SULFUR) SULFUR 12 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
GLYCYRRHIZA GLABRA
WATER
SODIUM BENZOATE
Product Characteristics
Color Score
Shape Size
Flavor GRAPE (Natural Grape Flavor) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54973-3243-1 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 118 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (54973-3243-1)
2 NDC:54973-3243-2 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
2 236 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (54973-3243-2)
3 NDC:54973-3243-3 5 mL in 1 POUCH None
4 NDC:54973-3243-4 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
4 148 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (54973-3243-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 02/10/2016
Labeler — Hyland’s Inc. (008316655)
Establishment
Name Address ID/FEI Operations
Hyland’s Inc. 008316655 manufacture (54973-3243), pack (54973-3243), label (54973-3243)

Revised: 09/2023 Hyland’s Inc.

HomeoLabels.com provides trustworthy package insert and label information about marketed homeopathic remedies as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by HomeoLabels.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

We source our database directly from the FDA's central repository of homeopathic remedy labels and package inserts, under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2024. All Rights Reserved.