Label: INFANTS GAS RELIEF- simethicone suspension/ drops
-
Contains inactivated NDC Code(s)
NDC Code(s): 17856-5894-1, 17856-5894-2, 17856-5894-3, 17856-5894-4, view more17856-5894-6, 17856-5894-7 - Packager: Atlantic Biologicals Corps
- This is a repackaged label.
- Source NDC Code(s): 0904-5894
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 30, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 0.3 mL)
- Purpose
- Use
- Warnings
-
Directions
- shake well before using
- 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
- fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby's mouth, toward 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
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
- Inactive ingredients
- HOW SUPPLIED
- INFANTS GAS RELIEF (SIMETHICONE) SUSPENSION/ DROPS
-
INGREDIENTS AND APPEARANCE
INFANTS GAS RELIEF
simethicone suspension/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17856-5894(NDC:0904-5894) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 20 mg in 0.3 mL Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) MALTITOL (UNII: D65DG142WK) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color white (off-white) Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17856-5894-4 60 in 1 CASE 06/30/2021 1 1.2 mL in 1 DOSE PACK; Type 0: Not a Combination Product 2 NDC:17856-5894-1 10 mL in 1 CUP; Type 0: Not a Combination Product 05/01/2015 06/30/2021 3 NDC:17856-5894-3 .3 mL in 1 SYRINGE; Type 0: Not a Combination Product 06/30/2021 4 NDC:17856-5894-7 120 in 1 BOX, UNIT-DOSE 06/30/2021 4 .3 mL in 1 SYRINGE; Type 0: Not a Combination Product 5 NDC:17856-5894-2 120 in 1 BOX, UNIT-DOSE 06/30/2021 5 0.6 mL in 1 SYRINGE; Type 0: Not a Combination Product 6 NDC:17856-5894-6 120 in 1 BOX, UNIT-DOSE 06/30/2021 6 0.6 mL in 1 SYRINGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 12/07/2010 Labeler - Atlantic Biologicals Corps (047437707) Establishment Name Address ID/FEI Business Operations Atlantic Biologicals Corps 047437707 RELABEL(17856-5894) , REPACK(17856-5894)
