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 = 1 teaspoonful)

Acetaminophen 160 mg

Purpose

Pain Reliever/Fever Reducer

Uses

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

Temporarily reduces fever.

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 6 doses in 24 hours, which is the maximum daily amount
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks everyday while using this product.

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
  • is on a sodium-restricted diet.

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.

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

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. Quick medical
attention is critical for adults/children even if you do not notice any signs or symptoms.

Directions

Weight (lbs.)          Age (years)             dosage-teaspoonful (tsp.)
 under 24 under 2 consult Physician
 24 to 35 2 to 3 1 tsp. (5 mL)
 36 to 47 4 to 5 1 1/2 tsp. (7.5 mL)
 48 to 59 6 to 8 2 tsp. (10 mL)
 60 to 71 9 to 10 2 1/2 tsp. (12.5 mL)
 72 to 95 11 3 tsp. (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, FD C RED #40, Glycerin, Polyethylene Glycol 400, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol Solution 70% & Sodium Benzoate.

Questions or Comments?

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

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

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image Enfit Syringe

image Oral Syringe

ACETAMINOPHEN 
acetaminophen elixir
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0175(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:17856-0175-35 in 1 SYRINGE10/25/2022
1NDC:17856-0175-160 in 1 BOX, UNIT-DOSE
1NDC:17856-0175-22.5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:17856-0175-65 in 1 SYRINGE10/25/2022
2NDC:17856-0175-4120 in 1 BOX, UNIT-DOSE
2NDC:17856-0175-52.5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:17856-0175-95 in 1 SYRINGE10/25/2022
3NDC:17856-0175-7120 in 1 BOX, UNIT-DOSE
3NDC:17856-0175-82.5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
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(17856-0175)

Revised: 11/2022
Document Id: ef0189e1-da65-4082-979e-f1dcaf970568
Set id: ed1583a6-5e10-462b-aba3-5f6137191ab5
Version: 3
Effective Time: 20221103
 
ATLANTIC BIOLOGICALS CORP.