pediacare gas relief drops dye free

pediacare gas relief drops dye free
SPL v2
SPL
SPL Set ID af3ba224-939c-488a-96fb-fe84018031bc
Route
oral
Published
Effective Date 2011-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
silicon dioxide (0.011 g) dimethicone (0.211 g)
Inactive Ingredients
citric acid monohydrate cellulose, microcrystalline propylene glycol sodium benzoate carboxymethylcellulose sodium sucralose xanthan gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph final active Since 2011-08-01

Purpose

Anti-Gas

Description

Drug Facts


Medication Information

Uses

relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods

Purpose

Anti-Gas

Directions
  • shake well before using

  • all dosages may be repeated as needed, after meals and at bedtime

  • fill enclosed dropper to recommended dosage level

Dose by weight or if weight information is not available, dose by age.

  • dispense liquid slowly into baby’s mouth, toward inner cheek

  • may mix with 1 oz. of cool water, infant formula or other suitable liquids

  • clean dropper after each use and replace original cap
age (yr) weight (lb) dose
infants under 2 under 24 0.3 mL
children 2 and over 24 and over 0.6 mL
Other Information
  • Do not freeze

  • Store at room temperature 20-25ºC (68-77ºF)

  • See bottle or box for lot number and expiration date
Inactive Ingredients

citric acid, flavor, microcrystalline cellulose, propylene glycol, sodium benzoate, sodium carboxymethylcellulose, sucralose, xanthan gum

Description

Drug Facts

Principal Display Panel

INFANTS 0-36 months

PediaCare® we care for kidsTM

Gas Relief DROPS

SIMETHICONE-ANTI GAS

NON-STAINING

1 FL OZ (30 mL)

Section 42229-5

Drug Facts

Active Ingredient

(in each 0.3 mL)

Simethicone Emulsion USP 66.7mg/Simethicone 20 mg

Questions Or Comments?

call 1-888-474-3099 Mon. – Fri. 8 am to 8 pm EST or visit us at PediaCare.com







When Using This Product

do not exceed 12 doses per day

Keep Out of Reach of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.


Structured Label Content

Uses

relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods

Purpose

Anti-Gas

Directions
  • shake well before using

  • all dosages may be repeated as needed, after meals and at bedtime

  • fill enclosed dropper to recommended dosage level

Dose by weight or if weight information is not available, dose by age.

  • dispense liquid slowly into baby’s mouth, toward inner cheek

  • may mix with 1 oz. of cool water, infant formula or other suitable liquids

  • clean dropper after each use and replace original cap
age (yr) weight (lb) dose
infants under 2 under 24 0.3 mL
children 2 and over 24 and over 0.6 mL
Other Information (Other information)
  • Do not freeze

  • Store at room temperature 20-25ºC (68-77ºF)

  • See bottle or box for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

citric acid, flavor, microcrystalline cellulose, propylene glycol, sodium benzoate, sodium carboxymethylcellulose, sucralose, xanthan gum

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

INFANTS 0-36 months

PediaCare® we care for kidsTM

Gas Relief DROPS

SIMETHICONE-ANTI GAS

NON-STAINING

1 FL OZ (30 mL)

Section 42229-5 (42229-5)

Drug Facts

Active Ingredient (Active ingredient)

(in each 0.3 mL)

Simethicone Emulsion USP 66.7mg/Simethicone 20 mg

Questions Or Comments? (Questions or comments?)

call 1-888-474-3099 Mon. – Fri. 8 am to 8 pm EST or visit us at PediaCare.com







When Using This Product (When using this product)

do not exceed 12 doses per day

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.


Advanced Ingredient Data


Raw Label Data

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