BABY GAS DROPS- silver nitrate, ferula sumbul root, activated charcoal, chamomile, cinchona officinalis bark, citrullus colocynthis fruit, lycopodium clavatum spore, nutmeg, and sepia officinalis juice liquid

Baby Gas Drops by

Drug Labeling and Warnings

Baby Gas Drops by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc., LGM Pharma Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.
Argentum Nitricum 12X HPUS	gas, stomach pressure and pain
Asafoetida 6X HPUS	swollen tummy, gas, restlessness
Carbo Vegetabilis 12X HPUS	gas especially after feeding, crying, burping
Chamomilla 6X HPUS	restlessness, fussiness, crying, groaning
Cinchona Officinalis 6X HPUS	gas discomfort, stomach pressure, colic, constipation
Colocynthis 6X HPUS	stomach pain and pressure, swollen tummy, disturbed sleep
Lycopodium 30X HPUS	hard tummy, bloating, burping
Nux Moschata 6X HPUS	stomach pressure, gas that disturbs sleep
Sepia 12X HPUS	hard, expanded tummy, stomach pressure and pain

Uses

Temporarily relieves the symptoms of gas, stomach pressure and pain, swollen tummy, restlessness, crying, burping, fussiness, groaning, gas discomfort, colic, constipation, disturbed sleep, hard tummy, and bloating.

Warnings

Stop use and ask a doctor if symptoms persist for more than 7 days or worsen.

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

Directions

• Measure only with the dosing dropper provided
• Do not use dropper with other products
• On dosing dropper, mL = milliliter
• Fill to prescribed level and dispense liquid slowly into baby's mouth, toward inner cheek
• For best results, clean dropper after each use

Newborns and infants under 2 years of age (or weight under 24 lb)

0.3 mL every 15 minutes for up to 8 doses until relieved; then every 2 hours as required.

Children over 2 years of age (or weight over 24 lb)

0.6 mL every 15 minutes for up to 8 doses until relieved; then every 2 hours as required.

Other information

• Do not use if imprinted foil inner seal is broken or missing
• Hyland's may be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659

Inactive ingredients

Citric Acid, Grape Flavor (natural), Hydroxyethyl Cellulose, Potassium Sorbate, Purified Water, Sodium Citrate, Vegetable Glycerine.

Questions or comments?

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Carton

NDC: 54973-3174-1

HOMEOPATHIC

SINCE 1903

Hyland's®

Baby

Natural

Relief

Gas Drops

NATURAL RELIEF OF GAS

DISCOMFORT AND PAIN*

▶ No Alcohol, Artificial Flavors, Dyes or Sweeteners

Natural Grape Flavor

1 FL. OZ.

(29.6 mL)

INGREDIENTS AND APPEARANCE

BABY GAS DROPS 
silver nitrate, ferula sumbul root, activated charcoal, chamomile, cinchona officinalis bark, citrullus colocynthis fruit, lycopodium clavatum spore, nutmeg, and sepia officinalis juice liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3174
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A)	SILVER NITRATE	12 [hp_X]  in 1 mL
FERULA SUMBUL ROOT (UNII: GLA4808EHQ) (FERULA SUMBUL ROOT - UNII:GLA4808EHQ)	FERULA SUMBUL ROOT	6 [hp_X]  in 1 mL
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10)	ACTIVATED CHARCOAL	12 [hp_X]  in 1 mL
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	6 [hp_X]  in 1 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	6 [hp_X]  in 1 mL
CITRULLUS COLOCYNTHIS FRUIT (UNII: 0E49E3V9U6) (CITRULLUS COLOCYNTHIS FRUIT - UNII:0E49E3V9U6)	CITRULLUS COLOCYNTHIS FRUIT	6 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	30 [hp_X]  in 1 mL
NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9)	NUTMEG	6 [hp_X]  in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	12 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)
GRAPE (UNII: 6X543N684K)
SORBIC ACID (UNII: X045WJ989B)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
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: 54973-3174-1	1 in 1 CARTON	01/15/2014
1		29.6 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		01/15/2014

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3174) , pack(54973-3174)

Establishment
Name	Address	ID/FEI	Business Operations
NEXGEN PHARMA, INC.		079424083	manufacture(54973-3174) , pack(54973-3174)