Infants: Package Insert and Label Information
INFANTS- dimethicone suspension/ drops
ATLANTIC BIOLOGICALS CORP.
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.
Active ingredient (in each 0.3 mL)
Simethicone 20 mg
Purpose
Antigas
Uses
relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods
Warnings
Keep out of reach of children. Overdose warning: In case of overdose get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.
Directions
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- shake well before using
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- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
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- only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.
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- remove cap and insert syringe into the bottle.
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- pull syringe up until filled to the prescribed level, simply push syringe back until you have reached the described level. Slowly dispense the liquid into your child’s mouth (towards inner cheek).
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- all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician.
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- do not exceed 12 doses per day.
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- dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids.
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- Replace cap tightly to maintain child resistance
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- mL = milliliter
| Age (yr) | Weight (lb) | Dose (mL) |
| infants under 2 | under 24 | 0.3 |
| children over 2 | over 24 | 0.6 |
Other information
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- tamper evident: do not use if printed seal under cap is broken or missing
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- Store at room temperature
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- do not freeze
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- see bottom panel for lot number and expiration date
Inactive ingredients
carboxymethylcellulose sodium, citric acid, flavors, microcrystalline cellulose, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum
Questions or comments?
1-800-645-2158
Principal Display Panel
Infants’
Simethicone Drops
Antigas
•Dye-free•Non-staining formula•No Saccharin•No Artificial Color•No Artificial Flavor
Distributed by:
ATLANTIC BIOLOGICALS CORP.
MIAMI, FL 33179
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| Labeler — ATLANTIC BIOLOGICALS CORP. (047437707) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| ATLANTIC BIOLOGICALS CORP. | 047437707 | relabel (17856-1303), repack (17856-1303) | |
Revised: 06/2021 ATLANTIC BIOLOGICALS CORP.
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