Label: INFANTS SILAPAP- acetaminophen solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 17856-0145-3 - Packager: Atlantic Biologicals Corps
- This is a repackaged label.
- Source NDC Code(s): 54838-145
- 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 May 5, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Uses
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Warnings
This product contains acetaminophen. Severe liver damage may occur if your child takes: Liver warning:
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
: 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. Sore throat warning
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Do not use
- with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product
liver disease. taking the blood thinning drug warfarin. Ask a doctor before use if your child has
Ask a doctor or pharmacist before use if your child is - When using this product
- Stop use and ask a doctor if
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KEEP OUT OF REACH OF CHILDREN
. Keep out of reach of children
: 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. Overdose warning
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Directions
■ ■ ■ 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 this product does not contain directions or complete warnings for adult use
do not give more than directed (see overdose warning)
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)
For accurate dosing follow dosing instructions using the enclosed dropper. Fill dropper to 0.8 mL or prescribed level, and dispense with a single firm squeeze of the dropper bulb. Store between 20° - 25°C (68° - 77°F)
Other information
- Inactive ingredients
- Comments
- INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS
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INGREDIENTS AND APPEARANCE
INFANTS SILAPAP
acetaminophen solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17856-0145(NDC:54838-145) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 80 mg in 0.8 mL Inactive Ingredients Ingredient Name Strength anhydrous citric acid (UNII: XF417D3PSL) FD&C yellow no. 6 (UNII: H77VEI93A8) methylparaben (UNII: A2I8C7HI9T) SACCHARIN SODIUM (UNII: SB8ZUX40TY) sodium benzoate (UNII: OJ245FE5EU) sodium citrate (UNII: 1Q73Q2JULR) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor CHERRY (wild cherry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17856-0145-3 1 mL in 1 SYRINGE; Type 0: Not a Combination Product 05/05/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/01/1997 Labeler - Atlantic Biologicals Corps (047437707) Registrant - Atlantic Biologicals Corps (047437707) Establishment Name Address ID/FEI Business Operations Atlantic Biologicals Corps 047437707 RELABEL(17856-0145) , REPACK(17856-0145)
