FDA.reportPublic FDA data

Novalgina Acetaminophen Pain and Fever for Childrens

Manufacturer
HBC Pharma, LLC | Gadal Laboratories, Inc
Effective date
2024-11-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:34:01

Label at a glance#

ProductNovalgina Acetaminophen Pain and Fever for Childrens
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

temporarily: ■ reduces fever ■ relieves minor aches and pains due to: ■ the common cold ■ flu ■ headache ■ sore throat ■ toothache

Dosage and administration

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 (l...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen, 160mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily:

■ reduces fever

■ relieves minor aches and pains due to: ■ the common cold ■ flu ■ headache ■ sore throat ■ toothache

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

has liver disease

Ask a doctor or pharmacist before use if your

OTC - ASK DOCTOR/PHARMACIST SECTION

child is taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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

OVERDOSAGE SECTION


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

DOSAGE & ADMINISTRATION SECTION


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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION


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?

OTC - QUESTIONS SECTION


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

Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabelPackPack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN4
307668acetaminophen 32 MG/ML Oral SuspensionSCD4
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY4
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY4
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY4
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY4
307668APAP 32 MG/ML Oral SuspensionSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83057-0003-6Novalgina Acetaminophen Pain and Fever for Childrens125 mL in 1 BOTTLESUSPENSION1254
83057-0003-6Novalgina Acetaminophen Pain and Fever for Childrens1 in 1 CARTONSUSPENSION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83057-0003NOVALGINA ACETAMINOPHEN PAIN AND FEVER FOR CHILDRENS (ACETAMINOPHEN 160MG) SUSPENSION [HBC PHARMA, LLC]42 package rows20241105_fa2dc6d6-7e79-46f7-e053-6294a90aeae2.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83057-000383057-0003-6

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CORN SYRUP9G5L16BK6NIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
SORBITOL506T60A25RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM CITRATE1Q73Q2JULRIACT
FD&C RED NO. 40WZB9127XOAIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
ACETAMINOPHEN362O9ITL9DACTIB
PROPYLPARABENZ8IX2SC1OHIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2618ebb8-e99c-4203-e063-6294a90aa00afa2dc6d6-7e79-46f7-e053-6294a90aeae22024-11-04WarningsExact identifier
spl id: 2618ebb8-e99c-4203-e063-6294a90aa00a
spl set id: fa2dc6d6-7e79-46f7-e053-6294a90aeae2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.