Indications and uses
Relieves discomfort of infant gas frequently caused by excessive swallowing of air or certain formulas or food
LITTLE REMEDIES INFANT ESSENTIALS
- Manufacturer
- Medtech Products Inc.
- Effective date
- 2020-01-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:02:47
Label at a glance#
ProductLITTLE REMEDIES INFANT ESSENTIALS
Active ingredientDIMETHICONE, GINGER, FENNEL
Label structure12 sections
Dosage and administration
■ shake well before using ■ only use enclosed syringe; fill to prescribed level and dispense liquid slowly into child’s mouth, toward inner cheek ■ all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per day. ■ dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids ■ for best results, clean syringe after each u...
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
GAS RELIEF DROPS Simethicone / Antigas
Drug Facts
Purpose
Simethicone Emulsion USP 66.7 mg/ Simethicone 20 mg . . . . . . . . . . . . . . . ……..Antigas
Uses
Relieves discomfort of infant gas frequently caused by excessive swallowing of air or certain formulas or food
Warnings
Keep out of reach of children.
Directions
■ shake well before using
■ only use enclosed syringe; fill to prescribed level and dispense liquid slowly into child’s mouth, toward inner cheek
■ all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per day.
■ dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids
■ for best results, clean syringe after each use and replace original cap
If possible, use weight to determine dose; otherwise use age.
mL = milliliters
| Age (yrs) | Weight (lbs) | Dose |
| Newborns & Infants under 2 years | under 24 | 0.3 mL |
| Children 2 years and over | 24 and over | 0.6 mL |
Other information
■ do not freeze ■ store at room temperature 20˚-25˚C (68˚-77˚F)
■ See bottle or box for lot number and expiration date
Inactive ingredients
carmellose sodium,citric acid, microcrystalline cellulose, natural strawberry flavor, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum
GRIPE WATER
| Supplement Facts Serving Size: 5 mL Servings per Container: about 12 | |
| Amount per Serving | % Daily Value |
| Zingiber officinale (Ginger) Root Extract 5 mg | † |
| Foeniculum vulgare (Fennel) Seed Extract 4mg | † |
| †Daily Value not established | |
Other ingredients
purified water, agave, glycerin, natural ginger flavor, potassium sorbate, citric acid, xanthan gum
| Suggested Use | |
| Age | Dose |
| 2 to 4 weeks | 2.5 mL |
| 1 to 6 months | 5 mL |
| 6 months and older | 10 mL |
| Adults | 30 mL |
SHAKE WELL. May be taken directly using the dispenser included. May be given up to six times in a 24 hour period. If necessary to repeat dosage, wait a minimum of 30 minutes. Do not use if safety seal is broken or missing.
Keep out of reach of children.
In some infants, a rare allergic reaction may occur. Do not exceed recommended dosage.
Do not use if
- child has a history of kidney failure or renal problems
- child is allergic to any of the ingredients in this product Always consult your health care provider before giving this or any supplement to an infant.
- Store at room temperature.
SALINE SPRAY + DROPS
Uses
–Helps loosen mucus secretions to aid aspiration and removal from nose and sinuses, allowing for easier breathing. For infants this can be assisted with the use of our specially designed “Soft Tip” Nasal Aspirator.
Warnings
Keep out of reach of children.
▪ The use of this dispenser by more than one person may spread infection.
▪ Wipe nozzle clean after each use.
Directions (For nasal use only)
▪ Infants: 2 to 6 drops in each nostril as often as needed or as directed by your doctor.
▪Children: 2 to 6 sprays or drops into each nostril as often as needed or as directed by a doctor.
Store at 20°-25°C (68°-77°F).
See bottle for lot and expiration date.
Ingredients:
water, sodium chloride, glycerin, sodium benzoate, benzoic acid
PRINCIPAL DISPLAY PANEL
Little Remedies®
Infant Essentials Kit
GAS DROPS
SIMETHICONE /ANTIGAS
1 FL OZ (30 mL)
Syringe Included
SALINE SPRAY + DROPS
0.5 FL OZ (15 mL)
GRIPE WATER
GINGER / FENNEL SUPPLEMENT
2 FL OZ (59 mL)
Syringe Included
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIMETHICONE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| GINGER Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63029-609-01 | 2023-01-30 | C162847 | 48780-1 | f386c649-abcb-0266-e053-dadaa90a7c1a | Little Remedies Infant Essentials Kit |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63029-609-01 | LITTLE REMEDIES INFANT ESSENTIALS | 1 in 1 CARTON | KIT | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63029-609 | LITTLE REMEDIES INFANT ESSENTIALS (SIMETHICONE EMULSION, SIMETHICONE, ZINGIBER OFFICINALE (GINGER) ROOT, FOENICULUM VULGARE (FENNEL) SEED) KIT [MEDTECH PRODUCTS INC.] | 1 | Legacy NDC, 1 package rows | 20200104_be96e634-0dae-4c0b-87b2-a000da2543d3.zip |
Products#
Every source-derived product name is available through these pages.
- LITTLE REMEDIES INFANT ESSENTIALS
- Simethicone Emulsion, Simethicone, Zingiber officinale (Ginger) Root, Foeniculum vulgare (Fennel) Seed
- LITTLE REMEDIES RELIEF
- SIMETHICONE
- DIMETHICONE
- CARBOXYMETHYLCELLULOSE SODIUM
- CITRIC ACID MONOHYDRATE
- CELLULOSE, MICROCRYSTALLINE
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SUCROSE
- XANTHAN GUM
- Saline
- GLYCERIN
- BENZOIC ACID
- SODIUM CHLORIDE
- Gripe Water
- Ginger Root / Fennel Seed
- GINGER
- FENNEL
- AGAVE TEQUILANA JUICE
- POTASSIUM SORBATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63029-609 | 63029-609-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 4923de4c-6a94-4018-9215-a36a7c5c8c13 | be96e634-0dae-4c0b-87b2-a000da2543d3 | 2020-01-01 | Warnings | 4923de4c-6a94-4018-9215-a36a7c5c8c13 be96e634-0dae-4c0b-87b2-a000da2543d3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.