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

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Hyland's 4 Kids Sore Throat Grape

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

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

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

Inactive ingredients

Citric Acid, Glycerine, Glycyrrhiza Extract, Natural Grape Flavor, 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 54973-4020-1

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

carton

4 KIDS SORE THROAT GRAPE 
spongia officinalis skeleton, roasted, aconitum napellus, phosphorus, calcium sulfide and ferrosoferric phosphate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-4020
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS9 [hp_X]  in 1 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS15 [hp_X]  in 1 mL
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED12 [hp_X]  in 1 mL
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-4020-11 in 1 CARTON02/14/2020
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/14/2020
Labeler - Hyland's Inc. (008316655)
Establishment
NameAddressID/FEIBusiness Operations
Applied Laboratories, Inc.117337220manufacture(54973-4020) , pack(54973-4020) , label(54973-4020)

Revised: 11/2022
Document Id: ee26e726-dfc2-3809-e053-2a95a90a59a3
Set id: a0c3adb0-e7a3-2ba3-e053-2a95a90ac79e
Version: 2
Effective Time: 20221123
 
Hyland's Inc.