CHILDRENS SILAPAP- acetaminophen liquid 
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.

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Children's Silapap Liquid

Active Ingredient: Acetaminophen 160 mg (in each 5 mL (TSP))

Purpose: Pain reliever/fever reducer

Uses To reduce fever and for the temporary relief of minor aches and pains due to:

Warnings

Liver Warning:This product contains acetaminophen. Severe liver damage may occur if you take:

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.

Alcohol warning:If the user consumes 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers.

Do not use

  • with any other product drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if the user is allergic to acetaminophen or any of the inactive ingredients in this product

When using this product

  • do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

  • 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 a serious condition

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center (1800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs of symptoms.

Directions


 children under 2 yrs (under 24 lbs)
 ask a doctor
 children 2-3 years (24-35 lbs)
 1 teaspoonful (TSP)(5 mL)
 children 4-5 years (36-47 lbs)
 1 1/2 teaspoonfuls (TSP)(7.5 mL)
 children 6-8 years (48-59 lbs)
 2 teaspoonfuls (TSP)(10 mL)
 children 9-10 years (60-71 lbs)
 2 1/2 teaspoonfuls (TSP)(12.5 mL)
 children 11 years (72-95 lbs)
 3 teaspoonfuls (TSP)(15 mL)
 adults & children 12 years & older
 4 teaspoonfuls (TSP)(20 mL)

Other information
Store at room temperature 20°-25°C (68°-77°F)

Inactive ingredients

citric acid, D&C red no. 33, FD&C red no. 40, cherry flavor, methylparaben, propylene glycol, saccharin sodium, sodium benzoate, and purified water.

Questions

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 NE 16TH PLACE 

MIAMI, FL  33179

ACETAMINOPHEN (SILAPAP)

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CHILDRENS SILAPAP 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0141(NDC:54838-144)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (cherry flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-0141-150 in 1 BOX, UNIT-DOSE01/15/2021
120.31 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:17856-0141-250 in 1 BOX, UNIT-DOSE01/15/2021
231.25 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
3NDC:17856-0141-350 in 1 BOX, UNIT-DOSE01/15/2021
315.6 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
4NDC:17856-0141-4120 in 1 BOX, UNIT-DOSE01/15/2021
42.5 mL in 1 SYRINGE; Type 0: Not a Combination Product
5NDC:17856-0141-572 in 1 BOX, UNIT-DOSE01/15/2021
55 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
6NDC:17856-0141-648 in 1 BOX, UNIT-DOSE01/15/2021
65 mL in 1 SYRINGE; Type 0: Not a Combination Product
7NDC:17856-0141-7120 in 1 BOX, UNIT-DOSE01/15/2021
71.25 mL in 1 SYRINGE; Type 0: Not a Combination Product
8NDC:17856-0141-8120 in 1 BOX, UNIT-DOSE01/15/2021
82.5 mL in 1 SYRINGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/15/2021
Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
NameAddressID/FEIBusiness Operations
ATLANTIC BIOLOGICALS CORP.047437707relabel(17856-0141) , repack(17856-0141)

Revised: 1/2021
Document Id: c6f3a706-ca2a-4114-8ad3-ea3ad911d000
Set id: 2d17a7a6-6b15-4281-a64c-04cb5eb0daaf
Version: 2
Effective Time: 20210115
 
ATLANTIC BIOLOGICALS CORP.