NOVALGINA ACETAMINOPHEN PAIN AND FEVER FOR CHILDRENS- acetaminophen 160mg suspension 
HBC Pharma, LLC

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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Novalgina Acetaminophen Pain and Fever for Children's

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 yearsAsk a doctor
24-35 lbs.2 - 3 years

5 mL

36-47 lbs.4-5 years7.5
48-59 lbs.6-10 Years

10 mL

60-71 lbs9-10 years

12.5 mL

72-95 lbs11 years15 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

labelPack

NOVALGINA ACETAMINOPHEN PAIN AND FEVER FOR CHILDRENS 
acetaminophen 160mg suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83057-0003
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
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    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83057-0003-61 in 1 CARTON07/15/2023
1125 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/08/2023
Labeler - HBC Pharma, LLC (063580631)
Establishment
NameAddressID/FEIBusiness Operations
Gadal Laboratories, Inc841305639manufacture(83057-0003)

Revised: 10/2023
Document Id: 06c113f5-63bb-f431-e063-6294a90a7d4f
Set id: fa2dc6d6-7e79-46f7-e053-6294a90aeae2
Version: 3
Effective Time: 20231002
 
HBC Pharma, LLC