4 KIDS STUFFY NOSE AND SINUS- pulsatilla pratensis whole,oyster shell calcium carbonate, crude,goldenseal and potassium dichromate tablet

4 Kids Stuffy Nose and Sinus by

Drug Labeling and Warnings

4 Kids Stuffy Nose and Sinus by is a Homeopathic medication manufactured, distributed, or labeled by Hyland’s Inc., Hyland's Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Calcarea Carbonica 3X HPUS

Hydrastis Canadensis 6X HPUS

Kali Bichromicum 6X HPUS

Pulsatilla Nigricans 6X HPUS

"HPUS" indicates that the active ingredients are in the official Homeopathic

Pharmacopœia of the United States.

Purpose

sinus pressure, congestion, headache

sinus headache

nasal congestion, sinus pressure

sinus pressure, headache

Uses

• Temporarily relieves symptoms of stuffy nose and sinus in children, including:
• nasal congestion 
• sinus pressure 
• headache

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 72 hours or worsen.
• symptoms are accompanied by a high fever (over 101°F).

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

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:

  Dissolve 1 tablet under tongue every 4 hours

  until relieved, up to 72 hours.

• Children 6 years to under 12 years:

  Dissolve 2 tablets under tongue every 4 hours

  until relieved, up to 72 hours.

• Adults and children 12 years and over:

  Dissolve 3 tablets under tongue every 4 hours

  until relieved, up to 72 hours.

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.

Inactive ingredients

Acacia Gum, Lactose.

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

HOMEOPATHIC

NDC: 54973-3406-1

2-12

YEARS

NEW

4 KIDS

SINCE 1903

Hyland's

Stuffy Nose

& Sinus*

Relieves nasal congestion,

sinus preasure and headache

NO ARTIFICIAL FLAVORS

NO DYES or PARABENS

NATURAL

RELIEF

50 QUICK-DISSOLVING

TABLETS

*SEE NOTE ON BACK

PANEL BELOW DRUG FACTS

INGREDIENTS AND APPEARANCE

4 KIDS STUFFY NOSE AND SINUS 
pulsatilla pratensis whole,oyster shell calcium carbonate, crude,goldenseal and potassium dichromate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3406
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V)	POTASSIUM DICHROMATE	6 [hp_X]
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	3 [hp_X]
PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI)	PULSATILLA PRATENSIS WHOLE	6 [hp_X]
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3406-1	1 in 1 CARTON	01/27/2020
1		50 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		01/27/2020

Labeler - Hyland’s Inc. (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3406) , pack(54973-3406) , label(54973-3406)