COUGH WITH 100% NATURAL HONEY 4 KIDS- ipecac, aconitum napellus, spongia officinalis skeleton, roasted, and antimony potassium tartrate syrup

Cough with 100% Natural Honey 4 Kids by

Drug Labeling and Warnings

Cough with 100% Natural Honey 4 Kids by is a Homeopathic medication manufactured, distributed, or labeled by Hylands Inc., Lifetech Resources, Applied Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Temporarily relieves the symptoms of the common cold including moist, dry, tight or tickling coughs, and chest congestion.

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
" HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Aconitum Napellus 6X HPUS	hoarse, dry, croupy cough, chest congestion
Antimonium Tartaricum 6X HPUS	moist cough
Ipecacuanha 6X HPUS	moist, gagging cough
Spongia Tosta 6X HPUS	dry, barking cough

Uses

Temporarily relieves the symptoms of the common cold including moist, dry, tight or tickling coughs, and chest congestion.

Warnings

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

• Symptoms persist for more than 7 days or worsen
• Cough tends to recur or is accompanied by high fever, rash or persistent headache

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or a poison control center immediately.

Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed health care professional.

A persistent cough may be a sign of a serious condition.

Do not use if imprinted tamper band is broken or missing.

In case of emergency, 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.

Drug Facts (continued)

Directions

• Measure only with the dosing cup provided
• Do not use dosing cup with other products
• On dosing cup, tsp = teaspoon

• Children 2 years to under 6 years: 5 mL or 1 teaspoon every 15 minutes for up to 4 doses until relieved; then every 4 hours as required
• Children 6 years to under 12 years: 10 mL or 2 teaspoons every 15 minutes for up to 4 doses until relieved; then every 4 hours as required
• Adults and children 12 years and over: 15 mL or 3 teaspoons every 15 minutes for up to 4 doses until relieved; then every 4 hours as required

Inactive ingredients

Cane Sugar, Citric Acid, Glycerine, Honey, Purified Water, Sodium Benzoate.

Questions or comments?

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

Natural
Relief

NDC: 54973-7520-1
HOMEOPATHIC*

Ages
2-12

SINCE 1903
Hyland's
4Kids

Cough
Syrup

with 100% Natural Honey

Chest
Congestion

Cough

ALCOHOL FREE
DYE FREE

SAFE &
EFFECTIVE

4 FL. OZ. (118 mL)

INGREDIENTS AND APPEARANCE

COUGH WITH 100% NATURAL HONEY 4 KIDS 
ipecac, aconitum napellus, spongia officinalis skeleton, roasted, and antimony potassium tartrate syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-7520
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	6 [hp_X]  in 1 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	6 [hp_X]  in 1 mL
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID)	SPONGIA OFFICINALIS SKELETON, ROASTED	6 [hp_X]  in 1 mL
ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5)	ANTIMONY POTASSIUM TARTRATE	6 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HONEY (UNII: Y9H1V576FH)
WATER (UNII: 059QF0KO0R)
SUGARCANE (UNII: 81H2R5AOH3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-7520-1	1 in 1 CARTON	08/01/2008
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 54973-7520-3	1 in 1 CARTON	08/01/2008
2		19.8 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		08/01/2008

Labeler - Hylands Inc. (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-7520) , pack(54973-7520)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources		622559110	manufacture(54973-7520) , pack(54973-7520)

Establishment
Name	Address	ID/FEI	Business Operations
Applied Laboratories, Inc.		876754375	manufacture(54973-7520) , pack(54973-7520) , label(54973-7520)