Infants Pain and Fever

Manufacturer
Bi-Mart | Aurohealth LLC
Effective date
2020-11-19
Label type
Human OTC Drug Label
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:05:00

Label at a glance#

ProductInfants Pain and Fever
Active ingredientACETAMINOPHEN
Label structure14 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

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 find right dose on chart. If possible, use weight to dose; otherwise, use age. use only enclosed syringe designed for use with this product. Do not use any other dosing device. remove bottle cap and insert syringe tip through opening at top of t...

Storage and handling

each 5 mL contains: sodium 6 mg store at 20°-25°C (68°-77°F) do not use if printed bottle body wrap is broken or missing see bottom panel for lot number and expiration date

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL)

Acetaminophen, USP 160 mg

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
  • 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.

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.
  • for more than 10 days for pain unless directed by a doctor.
  • for more than 3 days for fever unless directed by a doctor.
  • 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

OTC - ASK DOCTOR SECTION

liver disease

Ask a doctor or pharmacist before use if your child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dose (see overdose warning)

Stop using and ask a doctor if

OTC - STOP USE SECTION

  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse

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). Prompt 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

  • 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
  • find right dose on chart. If possible, use weight to dose; otherwise, use age.
  • use only enclosed syringe designed for use with this product. Do not use any other dosing device.
  • remove bottle cap and insert syringe tip through opening at top of the bottle
  • tip bottle upside down and draw medicine into the syringe
  • fill to dose level
  • dispense liquid slowly into child’s mouth, toward inner cheek
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • replace cap tightly to maintain child resistance
Dosing Chart
* or as directed by a doctor
Weight (lb)
Age (yr)
Dose (mL)*
under 24
under 2 years
ask a doctor
24-35
2-3 years
5 mL

Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: sodium 6 mg
  • store at 20°-25°C (68°-77°F)
  • do not use if printed bottle body wrap is broken or missing
  • see bottom panel for lot number and expiration date

Inactive Ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

1 - 800 - 935 - 6737


Distributed by:
BI-MART, Eugene, OR 97402

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 2 FL OZ (59 mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIMART         NDC 37835-711-11
Compare to active ingredient of
Infants’ TYLENOL® Oral Suspension**

Infants'
Pain & Fever
Pain Reliever & Fever Reducer

ACETAMINOPHEN
ORAL SUSPENSION
160 mg per 5 mL

-
Alcohol Free
- Aspirin Free
- Ibuprofen Free

Dye-Free
Cherry Flavor

Use ONLY enclosed syringe

2 FL OZ (59 mL)


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 1 FL OZ (30 mL)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 1 FL OZ (30 mL)


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
37835-71137835-711-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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
a706a270-9ef5-4dc1-b2d4-3c0034bca7f6294aae8d-79c0-4179-be23-beb0770d748e2020-11-19WarningsExact identifier
spl id: a706a270-9ef5-4dc1-b2d4-3c0034bca7f6
spl set id: 294aae8d-79c0-4179-be23-beb0770d748e

Reported adverse events (FAERS/openFDA)#

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