Infants Simethicone
Dosage form: solution/ drops
Ingredients: SIMETHICONE 63.3mg in 1mL, SILICON DIOXIDE 3.7mg in 1mL
Labeler: Qualitest Pharmaceuticals
NDC Code: 0603-0894
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.
Simethicone 20 mg
Anti-gas
Relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
- 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 the inner cheek
- dosage can also be mixed with 1 oz of cool water, infant formula or other suitable liquids
- for best results, clean dropper after each use and replace original cap
| Age | Weight | Dose |
| infants under 2 years | under 24 lbs | 0.3 mL |
| children over 2 years | over 24 lbs | 0.6 mL |
- store at room temperature 15°- 30°C (59°- 86°F)
- do not freeze
You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.
carbomer, citric acid, FD&C red #3, flavor, hypromellose, purified water, saccharin sodium, sodium benzoate, sodium citrate
Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811
Rev. 3/15 R8
8276455 0894
| INFANTS SIMETHICONE
simethicone solution/ drops |
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| Labeler - Qualitest Pharmaceuticals (011103059) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Vintage Pharmaceuticals-Huntsville | 825839835 | ANALYSIS(0603-0894), LABEL(0603-0894), MANUFACTURE(0603-0894), PACK(0603-0894) | |
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.
