Walgreens Children's Dye - Free Pain & Fever

Childrens Dye Free Pain and Fever, 20 Single Doses x 5 mL ea by

Drug Labeling and Warnings

Childrens Dye Free Pain and Fever, 20 Single Doses x 5 mL ea by is a Otc medication manufactured, distributed, or labeled by Walgreens, New Vision Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CHILDRENS DYE FREE PAIN AND FEVER, 20 SINGLE DOSES X 5 ML EA- acetaminophen solution 
Walgreens

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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Walgreens Children's Dye - Free Pain & Fever

Active Ingredient (in each 5mL)

Acetaminophen, 160mg

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 for this product with other drugs containing acetamintophen.
Sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by physician.
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.

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

for more than 10 days for pain unless directed by a doctor

for more than 3 days for fever unless directed by a doctor

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

Stop use and ask a doctor if

pain gets worse or last more than 5 days

fever gets worse or last 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

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms. (1-800-222-1222)

Directions

do not give more than directed (see overdose warning)

use the chart below to confirm dose. If possible, use weight to confirm, otherwise use age

give the recommended number of vials below.

empty each Single-Use Vial required of all liquid when dosing

if needed, repeat dose every 4 hours while symptoms last

do not give more than 5 times in 24 hours

do not give for more than 5 days unless directed by a doctor

this product does not contain directions or complete warnings for adult use.

How to Open & Use:

1. Flick the tip before opening so liquid descends.
2. Twist the tip until open and discard immediately.
3. Place open end into child’s mouth and Squeeze to dispense all liquid and discard.

Dosing Chart

Weight (lbs)Age (YearsDose (mL)
under 24 lbsunder 2 yearsTalk to a doctor
24 - 35 lbs2 - 3 years

1 Single-Use Vial (5 mL) Every 4 hours while symptoms last.

Do not exceed 5 Single-Use Vials in 24 hours.

Other Information

  • each Single-Use Vial contains 6mg of sodium
  • store at 20-25ºC (68-77ºF)
  • tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken

Inactive Ingredients

citric acid, edetate disodium, glycerin, grape flavor, maltitol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum.

Questions or Comments?

+1-800-925-4733

Package Labeling

Package

CHILDRENS DYE FREE PAIN AND FEVER, 20 SINGLE DOSES X 5 ML EA 
acetaminophen solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0363-3464
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
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
WATER (UNII: 059QF0KO0R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
MALTITOL (UNII: D65DG142WK)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0363-3464-2020 in 1 CARTON07/31/2020
15 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/31/202007/31/2020
Labeler - Walgreens (008965063)
Establishment
NameAddressID/FEIBusiness Operations
New Vision Pharmaceuticals LLC117900417manufacture(0363-3464) , pack(0363-3464) , analysis(0363-3464)

Revised: 12/2021

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