rel infant drops

rel infant drops
SPL v3
SPL
SPL Set ID b479bf22-3469-7916-e053-2995a90addc8
Route
oral
Published
Effective Date 2012-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (20 mg)
Inactive Ingredients
carboxymethylcellulose sodium anhydrous citric acid maltitol cellulose, microcrystalline water sodium benzoate sodium citrate xanthan gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2020-02-01
Purpose

Antigas

Description

Simethicone 20 mg

Medication Information

Warnings



Purpose

Antigas

Directions
  • 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
  • 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

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

Description

Simethicone 20 mg

Use

relieves the symptoms referred to as gas

Section 50565-1

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

Package Label

Questions Or Comments?

call 516-341-0666

8:30 am - 4:30 pm ET,

Monday - Friday

Active Ingredient (in Each 0.3 Ml)

Simethicone 20 mg

Structured Label Content

Warnings



Purpose

Antigas

Directions
  • 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 (Other information)
  • 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 ingredients)

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

Use

relieves the symptoms referred to as gas

Section 50565-1 (50565-1)

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

Package Label (package Label)

Questions Or Comments? (Questions or comments?)

call 516-341-0666

8:30 am - 4:30 pm ET,

Monday - Friday

Active Ingredient (in Each 0.3 Ml) (Active ingredient (in each 0.3 mL))

Simethicone 20 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:17.328532 · Updated: 2026-03-14T23:01:42.949822