CHILDREN ACETAMINOPHEN ORAL SOLUTION- 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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Active ingredient (per 5 mL teaspoonful)

Acetaminophen 160 mg

Purpose

Pain Reliever/Fever Reducer

Uses

Warnings

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

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

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

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have liver disease.

Ask a doctor before use if you are taking the blood thinning drug warfarin.

When using this product: Do not exceed recommended dose.

Stop use and ask a doctor if

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

Keep out of reach of children. In case of overdose, get medical help or contact a Paoison 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) under 24 24-35 36-4748-59  60-71 72-95 over 95
Age (years)  under 2 2 to 3 4 to 5 6 to 8 9 to 10 11 12 to adult
Dosage Teaspoonful (tsp)  consult Physician 1 tsp (5 mL) 1 1/2 tsp (7.5 mL) 2 tsp (10 mL) 2 1/2 tsp (12.5 mL) 3 tsp (15 mL) 4 tsp (20 mL)

Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

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CHILDREN ACETAMINOPHEN ORAL SOLUTION 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-7014(NDC:0904-7014)
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)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-7014-172 in 1 BOX, UNIT-DOSE02/05/2020
15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:17856-7014-248 in 1 BOX, UNIT-DOSE02/05/2020
25 mL in 1 SYRINGE; Type 0: Not a Combination Product
3NDC:17856-7014-350 in 1 BOX, UNIT-DOSE02/05/2020
315.6 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
4NDC:17856-7014-4120 in 1 BOX, UNIT-DOSE02/05/2020
42.5 mL in 1 SYRINGE; Type 0: Not a Combination Product
5NDC:17856-7014-5120 in 1 BOX, UNIT-DOSE02/05/2020
51.25 mL in 1 SYRINGE; Type 0: Not a Combination Product
6NDC:17856-7014-6120 in 1 BOX, UNIT-DOSE02/05/2020
62.5 mL in 1 SYRINGE; Type 0: Not a Combination Product
7NDC:17856-7014-750 in 1 BOX, UNIT-DOSE02/05/2020
720.31 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
8NDC:17856-7014-850 in 1 BOX, UNIT-DOSE02/05/2020
831.2 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
9NDC:17856-7014-972 in 1 BOX, UNIT-DOSE03/20/2020
910.15 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 finalpart34310/01/2019
Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
NameAddressID/FEIBusiness Operations
ATLANTIC BIOLOGICALS CORP.047437707relabel(17856-7014) , repack(17856-7014)

Revised: 3/2020
Document Id: 40bf292c-2f7a-427f-98b5-121dcbf0aa10
Set id: bda0d08a-042d-4430-bd88-1a44f607b71c
Version: 2
Effective Time: 20200320
 
ATLANTIC BIOLOGICALS CORP.