FRIDABABY CHILDREN PAIN AND FEVER ACETAMINOPHEN 160MG PER 5ML VIAL 10CT- acetaminophen 160mg per 5ml solution 
Fridababy LLC

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Fridababy Children Pain and Fever Acetaminophen 160mg per 5mL vial 10ct

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 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, persistent 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.

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 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.

In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt 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)

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

■ give the recommended number of vials below. To open, follow the instructions under How to Use.

■ 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

Weight (lbs)Age (Years)Dose
under 24 lbs.under 2 yearsAsk a doctor
24-35 lbs.2 - 3 years

1 Single Use Vial (5 mL)

36-47 lbs.4-5 yearsAsk a doctor
48-71 lbs.6-10 Years

2 Single Use Vial (10 mL)

72-95 lbs11 years3 Single Use Vial (15 mL)

Other Information

■ Each Single Use Vial contains 8mg of sodium

■ Store at 68-77°F (20-25°C)

■ Tamper Evident: do not use if the pouch is damaged, open or broken. Do not use if any vial is open or broken.

Inactive Ingredient

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

Questions or Comments?

1-833-WTF-FRIDA (1-833-983-3743)

Package

PDPDrug Facts Label

FRIDABABY CHILDREN PAIN AND FEVER ACETAMINOPHEN 160MG PER 5ML VIAL 10CT 
acetaminophen 160mg per 5ml solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72705-124
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
MALTITOL (UNII: D65DG142WK)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SORBITOL (UNII: 506T60A25R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72705-124-1010 in 1 POUCH08/16/2022
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 DrugM01308/16/202208/31/2024
Labeler - Fridababy LLC (783729598)

Revised: 12/2023
Document Id: 0cdf002b-72f7-a399-e063-6294a90a7e02
Set id: e42dc876-b35b-bf1e-e053-2a95a90a884b
Version: 4
Effective Time: 20231219
 
Fridababy LLC