CHILDREN ACETAMINOPHEN ORAL SOLUTION- acetaminophen liquid 
ATLANTIC BIOLOGICALS CORP.

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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-DOSE04/19/2024
15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:17856-7014-248 in 1 BOX, UNIT-DOSE04/19/2024
25 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:17856-7014-350 in 1 BOX, UNIT-DOSE04/19/2024
315.6 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
4NDC:17856-7014-4120 in 1 BOX, UNIT-DOSE04/19/2024
42.5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
5NDC:17856-7014-5120 in 1 BOX, UNIT-DOSE04/19/2024
51.25 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
6NDC:17856-7014-6120 in 1 BOX, UNIT-DOSE04/19/2024
62.5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
7NDC:17856-7014-750 in 1 BOX, UNIT-DOSE04/19/2024
720.31 mL in 1 CUP, UNIT-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
8NDC:17856-7014-850 in 1 BOX, UNIT-DOSE04/19/2024
831.2 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
9NDC:17856-7014-972 in 1 BOX, UNIT-DOSE04/19/2024
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 DrugM10/01/2019
Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
NameAddressID/FEIBusiness Operations
UNIT DOSE SOLUTIONS360804194repack(17856-7014)

Revised: 4/2024
Document Id: 62d78fb0-c1bb-4757-bb18-a899856dd6b0
Set id: bda0d08a-042d-4430-bd88-1a44f607b71c
Version: 3
Effective Time: 20240419
 
ATLANTIC BIOLOGICALS CORP.