RxNorm Names
LEADER INFANTS GAS RELIEF
(simethicone)
emulsion
[Cardinal Health]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=41936f0b-c098-4958-83c7-35a664034930| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | OTC monograph final |
NOTE: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.
Uses
Relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods
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 the inner cheek
- dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
- clean dropper after each use - replace bottle with original cap
| age (yr) | weight (lb) | dose |
| infants under 2 | under 24 | 0.3 mL |
| children over 2 | over 24 | 0.6 mL |
Other information
- do not use in printed seal under cap is torn or missing
- store at room temperature
- do not freeze
- see bottom panel for lot and expiration date
| LEADER INFANTS GAS RELIEF
simethicone emulsion |
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
| Labeler - Cardinal Health (097537435) |
Revised: 06/2009
Document Id: 41936f0b-c098-4958-83c7-35a664034930
Set id: 41936f0b-c098-4958-83c7-35a664034930
Version: 1
Effective Time: 20090604
Cardinal Health
Review RxNorm Normal Forms