ACETAMINOPHEN- acetaminophen elixir 
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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Acetaminophen Elxir

Bubble Gum Flavor

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain Reliever/Fever Reducer

Uses

trmporarily:

Warnings

Liver warning

This product contains acetaminophen.

Severe liver damage may occur if your child takes:

  • more than 5 doses in 24 hours, which is the maximum daily amount 
  • with other drugs containing acetaminophen.

Allergy alert:

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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.

Do not use

  • with any other drug containing acetaminophen (prescription or non-prescription). 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

Ask a doctor before use if your child has

  • liver disease

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

When using this product: Do not exceed recommended dose

Stop use and ask a doctor if:

  • Pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur.
  • redness or swelling is present.

These could be signs of a serious condition.

Keep out of reach of children.

Overdose Warning:

In case of overdose get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical
attention is critical even if you do not notice any signs or symptoms.

Directions

Weight (lbs.)          Age (years)             dosage-teaspoonful (tsp.)
 under 24 under 2 ask a doctor
 24 to 35 2 to 3 1 tsp or 5 mL
 36 to 47 4 to 5 1 1/2 tsp or 7.5 mL
 48 to 59 6 to 8 2 tsp or 10 mL
 60 to 71 9 to 10 2 1/2 tsp or 12.5 mL
 72 to 95 11 3 tsp or 15 mL

Other information

TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

Inactive Ingredients:

bubble gum flavor, citric acid, glycerin, polyethylene glycol 400, purified water, sodium citrate, saccharin sodium, sorbitol solution & sodium benzoate.

Questions or Comments?

Call (877) 225-6999 Monday - Friday 9AM-5PM EST

DISTRIBUITED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol Elixir

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ACETAMINOPHEN 
acetaminophen elixir
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0166(NDC:71399-0160)
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-0166-172 in 1 BOX, UNIT-DOSE03/13/2023
1NDC:17856-0166-210.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:17856-0166-350 in 1 BOX, UNIT-DOSE03/13/2023
2NDC:17856-0166-420.31 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
3NDC:17856-0166-750 in 1 BOX, UNIT-DOSE03/13/2023
3NDC:17856-0166-831.2 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
4NDC:17856-0166-572 in 1 BOX, UNIT-DOSE03/13/2023
4NDC:17856-0166-615 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/18/2021
Labeler - ATLANTIC BIOLOGICALS CORP (047437707)
Establishment
NameAddressID/FEIBusiness Operations
UNIT DOSE SOLUTIONS360804194repack(17856-0166)

Revised: 3/2023
Document Id: bbed8399-0702-43e3-a991-6ff6024a1cdd
Set id: 57b9b32c-6a5c-49d7-b4df-e0489a98168c
Version: 2
Effective Time: 20230313
 
ATLANTIC BIOLOGICALS CORP