Infant and Children Novex Acetaminophen
- Manufacturer
- Herbion Pakistan (Pvt.) Ltd
- Effective date
- 2020-03-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:39:38
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
(in each 5 mL)
Acetaminophen 160 mg
OTC - PURPOSE SECTION
Purpose:
fever reducer / Pain reliever
INDICATIONS & USAGE SECTION
Uses:
temporarily: ■ reduces fever ■ relieves minor aches and pains due to: ■ the common cold ■ flu ■ headache ■ sore throat ■ toothache
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 ■ 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
OTC - ASK DOCTOR SECTION
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
When using this product do not exceed recommended dose
(see overdose warning)
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.
OTC - DO NOT USE SECTION
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
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.
DOSAGE & ADMINISTRATION SECTION
Directions:
■ this product does not contain directions or complete warnings for adult use.
■ do not give more than directed (see overdose warning)
■ shake well before using
■ mL = milliliter; tsp = teaspoonful
■ find right dose on chart below. If possible, use weight to dose; otherwise, use age.
■ remove the child protective cap and use the dosing vial / measuring cup provided
■ repeat dose every 4 hours while symptoms last
■ do not give more than 5 times in 24 hours
Weight (lb) | Age (yr) | Dose (mL)* |
Under 24 | Under 2 years | Ask a doctor |
24-35 | 2-3 years | 5 mL |
36-47 | 4-5 years | 7.5 mL |
48-59 | 6-8 years | 10 mL |
60-71 | 9-10 years | 12.5 mL |
72-95 | 11 years | 15 mL |
*or as directed by a doctor
Attention: use only enclosed dosing devices provided, specifically designed for use with this product.
GENERAL PRECAUTIONS SECTION
Other Information
■ each 5 mL (1 tsp) contains: sodium 1.2 mg
■ store between 20-250C (68-770F)
■ do not use if bottle cap seal is broken
INACTIVE INGREDIENT SECTION
Inactive Ingredients:
Sucrose, Sorbitol, Glycerin, Flavor, Xanthan Gum, Sodium Benzoate, Potassium Sorbate, FD&C RED NO. 40, Purified Water
OTC - QUESTIONS SECTION
Questions or Comments?
Call 1-888-(OK-HERBION) 654-3724, Monday through Friday 9am - 5pm EST
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Products#
Every source-derived product name is available through these pages.
- Infant and Children Novex Acetaminophen
- ACETAMINOPHEN
- SUCROSE
- SORBITOL
- GLYCERIN
- XANTHAN GUM
- SODIUM BENZOATE
- POTASSIUM SORBATE
- WATER
- FD&C RED NO. 40
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 44237-040 | 44237-040-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| SUCROSE | C151H8M554 | IACT |
| SORBITOL | 506T60A25R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| POTASSIUM SORBATE | 1VPU26JZZ4 | IACT |
| WATER | 059QF0KO0R | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ddb4b2ff-0f6c-4be9-aa40-ec220fe92fe5 | ca7447ac-5210-4c10-96e8-abb5a488447f | 2021-07-28 | Warnings | ca7447ac-5210-4c10-96e8-abb5a488447f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
