4 KIDS SORE THROAT GRAPE- spongia officinalis skeleton, roasted, aconitum napellus, phosphorus, calcium sulfide and ferrosoferric phosphate liquid

4 Kids Sore Throat Grape by

Drug Labeling and Warnings

4 Kids Sore Throat Grape by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc., Applied Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Aconitum Napellus 15X HPUS

Ferrum Phosphoricum 12X HPUS

Hepar Sulphuris Calcareum 12X HPUS

Phosphorus 9X HPUS

Spongia Tosta 12X HPUS

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

Purpose

sore throat

sore throat

sore throat

pain in throat

sore throat

Uses

• Temporarily relieves sore throat symptoms in children, including:
• occasional minor irritation 
• pain

Warnings

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

Do not use more than directed

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).

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

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.

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.

Directions

• 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).

Drug Facts (continued)

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, Natural Grape Flavor, Purified Water, Sodium Benzoate.

Questions or comments?

(800) 624-9659

SPL UNCLASSIFIED SECTION

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

Principal Display Panel - 118 mL Bottle Carton

HOMEOPATHIC

NDC: 54973-4020-1

2-12

YEARS

NEW

4 KIDS

SINCE 1903

Hyland's

Sore

Throat*

Relieves minor

sore throat pain

and irritation

NO ALCOHOL or PARABENS

NO SUGAR or DYES

NATURAL

RELIEF

NATURAL

GRAPE

FLAVOR

4 FL. OZ (118 mL)

*SEE NOTE

ON SIDE PANEL

BELOW DRUG FACTS

INGREDIENTS AND APPEARANCE

4 KIDS SORE THROAT GRAPE 
spongia officinalis skeleton, roasted, aconitum napellus, phosphorus, calcium sulfide and ferrosoferric phosphate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-4020
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	12 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	9 [hp_X]  in 1 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	15 [hp_X]  in 1 mL
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID)	SPONGIA OFFICINALIS SKELETON, ROASTED	12 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-4020-1	1 in 1 CARTON	02/14/2020
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/14/2020

Labeler - Hyland's Inc. (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Applied Laboratories, Inc.		876754375	manufacture(54973-4020) , pack(54973-4020) , label(54973-4020)