NOVALGINA ACETAMINOPHEN PAIN AND FEVER FOR CHILDRENS- acetaminophen 160mg suspension

Novalgina Acetaminophen Pain and Fever for Childrens by

Drug Labeling and Warnings

Novalgina Acetaminophen Pain and Fever for Childrens by is a Otc medication manufactured, distributed, or labeled by HBC Pharma, LLC, Gadal Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

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.
• 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

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.

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

Do not give more than directed, this product does not contain directions or complete warnings for adult use, find right dose on
chart below. If possible, use weight to dose; otherwise, use age. Repeat dose every 4 hours while symptoms last, do not give more than 5 times in 24 hours. Attention use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Weight (lbs)	Age (Years)	Dose
under 24 lbs.	under 2 years	Ask a doctor
24-35 lbs.	2 - 3 years	5 mL
36-47 lbs.	4-5 years	7.5
48-59 lbs.	6-10 Years	10 mL
60-71 lbs	9-10 years	12.5 mL
72-95 lbs	11 years	15 ml

Other Information

■ Store between 20-25°C (68-77°F)

■ Don’t use if carton tape or bottle wrap imprinted with is broken or missing

Inactive Ingredient

Citric acid, corn syrup, FD&C red no. 40, glycerin, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben,
purified water, sodium citrate, sorbitol solution, natural and artificial strawberry flavor, sucralose.

Questions or Comments?

Call weekdays from 9:30 AM to 5 PM EST at Tel: 305 2618762

Package

INGREDIENTS AND APPEARANCE

NOVALGINA ACETAMINOPHEN PAIN AND FEVER FOR CHILDRENS 
acetaminophen 160mg suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83057-0003
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
CORN SYRUP (UNII: 9G5L16BK6N)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83057-0003-6	1 in 1 CARTON	07/15/2023
1		125 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	06/08/2023

Labeler - HBC Pharma, LLC (063580631)

Establishment
Name	Address	ID/FEI	Business Operations
Gadal Laboratories, Inc		841305639	manufacture(83057-0003)