DYE FREE INFANTS PAIN AND FEVER- acetaminophen suspension 
FAMILY DOLLAR SERVICES INC

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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Dye-Free Infants' Pain + Fever Drug Facts

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 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 (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 for adults as well as for children 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 (seeoverdose warning)
shake well before using
mL = milliliter
find right dose on chart. If possible, use weight to dose; otherwise, use age.
push air out of syringe. Insert syringe tip into bottle opening
flip bottle upside down. Pull yellow part of syringe to correct dose
dispense liquid slowly into child's mouth, toward inner cheek
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours
replace cap tightly to maintain child resistance
Dosing Chart
Weight (lb)Age (yr)Dose (mL) **

under 24

under 2 years

ask a doctor

24-35 lbs

2-3 years

5
mL

Attention: use only enclosed syringe specifically designed for use with this product.

Do not use any other dosing device.

Other information

Each 5 mL contains: sodium 2 mg
store at room temperature

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, sodium benzoate, purified water, sodium citrate dihydrate, sorbitol liquid, sucralose, xanthan gum

Questions?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Dye-Free Infants’ Tylenol® Oral Suspension*

NDC 55319-206-02

Dye-Free

Infants'
Pain + Fever

Acetaminophen

Oral Suspension
Pain Reliever-Fever Reducer

Free Of:

Dyes
Ibuprofen
Aspirin
Parabens
High Fructose Corn Syrup

Natural Grape Flavor

No Added Alcohol

Sugar Free

Use Only Enclosed Syringe

2 FL OZ (60 mL)
160 mg per 5 mL***

***Same as Children’s TYLENOL

*This Product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of the registered trademark Dye-Free Infants’ Tylenol® Oral Suspension.

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS BROKEN OR MISSING

IMPORTANT: Keep this carton for future reference on full labeling.

Family Dollar Dye-free Infants' Pain + Fever reliever Grape Flavor 2 FL OZ 60 mL
DYE FREE INFANTS PAIN AND FEVER 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-206
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)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITE (Dye Free) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-206-021 in 1 CARTON05/08/2023
160 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/08/2023
Labeler - FAMILY DOLLAR SERVICES INC (024472631)

Revised: 9/2023
Document Id: d55c7f7b-3b1d-4545-913e-984c4bd9654c
Set id: c15f745d-1036-46a7-8253-9f75475df3c7
Version: 2
Effective Time: 20230916
 
FAMILY DOLLAR SERVICES INC