REL infant drops

Manufacturer: RELIABLE 1 LABORATORIES | GCP Laboratories
Effective date: 2026-07-30
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: daily-update
Hydrated at: 2026-08-07 01:01:06

Label at a glance#

ProductINFANTS GAS RELIEF DROPS

Active ingredientDIMETHICONE

Label structure9 sections

Dosage and administration

shake well before using all dosages may be repeated as needed, after meals and at bedtime, or as directed by a physician only use the enclosed dropper do not exceed 12 doses per day fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids clean dropper well after...

Storage and handling

TAMPER-EVIDENT: Do not use if foil seal under the cap is broken or missing. store between 20°-25°C (68°-77°F) do not freeze see bottom panel for lot number and expiration date

Contacts and useful links#

PhoneLabel contact516-341-0666

Label contents#

Full prescribing information#

Active ingredient (in each 0.3 mL)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 20 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Use

INDICATIONS & USAGE SECTION

relieves the symptoms referred to as gas

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of overdose, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

shake well before using
all dosages may be repeated as needed, after meals and at bedtime, or as directed by a physician
only use the enclosed dropper
do not exceed 12 doses per day
fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek
dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids
clean dropper well after each use and replace original cap on bottle

Age (years)	Weight (lbs)	Dose
infants (under 2)	under 24	0.3 mL
children (2 and over)	24 and over	0.6 mL

Other information

STORAGE AND HANDLING SECTION

TAMPER-EVIDENT: Do not use if foil seal under the cap is broken or missing.
store between 20°-25°C (68°-77°F)
do not freeze
see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, citric acid, flavor, maltitol, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate, xanthan gum.

Questions or comments?

OTC - QUESTIONS SECTION

call 516-341-0666
8:30 am - 4:30 pm ET,
Monday - Friday

package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

INFANTS GAS RELIEF DROPS
Simethicone
DIMETHICONE
CARBOXYMETHYLCELLULOSE SODIUM
ANHYDROUS CITRIC ACID
MALTITOL
CELLULOSE, MICROCRYSTALLINE
WATER
SODIUM BENZOATE
SODIUM CITRATE
XANTHAN GUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69618-059	69618-059-51

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIMETHICONE	92RU3N3Y1O	ACTIB
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
MALTITOL	D65DG142WK	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
XANTHAN GUM	TTV12P4NEE	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
3	2023-11-07	full-release	2026-05-31 23:59:24

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
INFANTS GAS RELIEF DROPS	SIMETHICONE	RELIABLE 1 LABORATORIES	b479bf22-3469-7916-e053-2995a90addc8	2026-07-30	Warnings	Exact identifier ndc (package): 69618-059-51 ndc (product): 69618-059 ndc11 (package): 69618005951 spl id: 57d81e8a-6332-ae27-e063-6294a90a1cbc spl set id: b479bf22-3469-7916-e053-2995a90addc8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.