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

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

Drug Labeling and Warnings

Fridababy Children Pain and Fever Acetaminophen 160mg per 5mL vial 10ct by is a Otc medication manufactured, distributed, or labeled by Fridababy LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 years	Ask a doctor
24-35 lbs.	2 - 3 years	1 Single Use Vial (5 mL)
36-47 lbs.	4-5 years	Ask a doctor
48-71 lbs.	6-10 Years	2 Single Use Vial (10 mL)
72-95 lbs	11 years	3 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

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72705-124
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72705-124-10	10 in 1 POUCH	08/16/2022
1		5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	08/16/2022	08/31/2024

Labeler - Fridababy LLC (783729598)

Revised: 12/2023

Document Id: 0cdf002b-72f7-a399-e063-6294a90a7e02

34390-5

Set id: e42dc876-b35b-bf1e-e053-2a95a90a884b

Version: 4

Effective Time: 20231219