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

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

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

Uses

■ Temporarily relieves 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.

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

Keep this and all medications out of the 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 Flavoring, Purified Water, Sodium Benzoate.

Questions or comments?

(800) 624-9659

*CLAIMS BASED ON TRADITIONAL

HOMEOPATHIC PRACTICE, NOT ACCEPTED

MEDICAL EVIDENCE. NOT FDA EVALUATED.

DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

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

NATURAL

GRAPE FLAVOR

4 FL. OZ. (118 mL)

HOMEOPATHIC

carton..
(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 (028570695)
Registrant — Standard Homeopathic Company (Hyland’s) (008316655)
Establishment
Name Address ID/FEI Operations
Standard Homeopathic Company 008316655 manufacture (54973-3243), pack (54973-3243)
Establishment
Name Address ID/FEI Operations
Standard Homeopathic Company 080253323 manufacture (54973-3243), pack (54973-3243), label (54973-3243)
Establishment
Name Address ID/FEI Operations
Applied Laboratories, Inc. 876754375 manufacture (54973-3243), pack (54973-3243)

Revised: 12/2021 Hyland’s

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