GOOD NEIGHBOR PHARMACY CHILDRENS PAIN AND FEVER- acetaminophen suspension 
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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Amerisource Bergen Children’s Pain & Fever Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

reduces fever
relieves minor aches and pains due to:
the common cold
flu
headache
sore throat
toothache

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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if your child has ever had an allergic reaction to this product or any of its ingredients

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 (see overdose warning)

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 right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

this product does not contain directions or complete warnings for adult use
do not give more than directed (see overdose warning)
shake well before using
mL = milliliter
find right dose on chart below. If possible, use weight to dose; otherwise, use age.
remove the child protective cap and squeeze your child’s dose into the dosing cup
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours

Weight (lb)

Age (yr)

Dose (mL)*

under 24

under 2 years

ask a doctor

24-35

2-3 years

5 mL

36-47

4-5 years

7.5 mL

48-59

6-8 years

10 mL

60-71

9-10 years

12.5 mL

72-95

11 years

15 mL

*or as directed by a doctor

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

each 5 mL contains: sodium 3 mg
store at 20-25°C (68-77°F)
do not use if printed neckband is broken or missing

Inactive ingredients

anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate.

Questions or comments?

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP. 

20101 N.E 16TH PLACE

MIAMI, FL 33179

Compare to Children’s Tylenol® Oral Suspension active ingredient

FOR AGES 2 TO 11 YEARS

children’s

Pain & Fever

acetaminophen 160 mg per 5 mL

oral suspension

Fever Reducer – Pain Reliever

Aspirin Free

Ibuprofen Free

Alcohol Free

Grape Flavor

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GOOD NEIGHBOR PHARMACY CHILDRENS PAIN AND FEVER 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0209(NDC:46122-211)
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)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CALCIUM SULFATE (UNII: WAT0DDB505)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)  
Product Characteristics
ColorPURPLE (viscous) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-0209-1120 in 1 BOX, UNIT-DOSE01/18/2021
11.5 mL in 1 SYRINGE; Type 0: Not a Combination Product
2NDC:17856-0209-2120 in 1 BOX, UNIT-DOSE01/18/2021
22 mL in 1 SYRINGE; Type 0: Not a Combination Product
3NDC:17856-0209-3120 in 1 BOX, UNIT-DOSE01/18/2021
33 mL in 1 SYRINGE; Type 0: Not a Combination Product
4NDC:17856-0209-4120 in 1 BOX, UNIT-DOSE01/18/2021
43.75 mL in 1 SYRINGE; Type 0: Not a Combination Product
5NDC:17856-0209-572 in 1 BOX, UNIT-DOSE01/18/2021
55 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
6NDC:17856-0209-648 in 1 BOX, UNIT-DOSE01/18/2021
66 mL in 1 SYRINGE; Type 0: Not a Combination Product
7NDC:17856-0209-748 in 1 BOX, UNIT-DOSE01/18/2021
77.5 mL in 1 SYRINGE; Type 0: Not a Combination Product
8NDC:17856-0209-872 in 1 BOX, UNIT-DOSE01/18/2021
810.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
9NDC:17856-0209-950 in 1 BOX, UNIT-DOSE01/18/2021
915 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 finalpart34305/22/2019
Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
NameAddressID/FEIBusiness Operations
ATLANTIC BIOLOGICALS CORP.047437707relabel(17856-0209) , repack(17856-0209)

Revised: 1/2021
Document Id: 37937b4f-c610-4caf-9d54-13467b37bad6
Set id: acb070bc-102a-4037-9bc4-1fa147583059
Version: 2
Effective Time: 20210118
 
ATLANTIC BIOLOGICALS CORP.