INFANTS SILAPAP
-
acetaminophen solution/ drops
Silarx Pharmaceuticals, Inc
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.
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temporarily:
■ reduces fever
■ relieves minor aches and pains due to:
Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
■ new symptoms occur
■ redness or swelling is present
■ pain gets worse or lasts for more than 5 days
■ fever gets worse or lasts for more than 3 days.
These could be signs of serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away, (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.
■ this product does not contain directions or complete warnings for adult use
■ do not give more than directed (see overdose warning)
■ find right dose on chart, if possible use weight to dose; otherwise, use age
■ use only enclosed dropper designed for use with this product, do not use any other dosing device
■ fill to dose level
■ dispense liquid slowly into child's mouth, toward inner cheek
■ may be given alone or mixed with formula, milk, juice etc.
■ If needed, repeat dose every 4 hours
■ do not give more than 5 times in 24 hours
■ Replace dropper tightly to maintain child resistance
Weight (lb) | Age (yr) | Dose (mL) |
under 24 | under 2 years | ask a doctor |
24-35 | 2-3 years | 1.6 mL (0.8 + 0.8 mL) |
citric acid, FD&C yellow no. 6, cherry flavor, methylparaben, saccharin sodium, sodium benzoate, sodium citrate, propylene glycol and purified water.
1-888-974-5279
Manufactured by:
Silarx Pharmaceuticals, Inc.
19 West St.
Spring Valley , NY 10977
INFANTS SILAPAP
acetaminophen solution/ drops |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph not final | part343 | 04/01/1997 |
Labeler - Silarx Pharmaceuticals, Inc (161630033) |
Revised: 11/2011 Silarx Pharmaceuticals, Inc