Infants Pain and Fever

Manufacturer
Rugby Laboratories, Inc.
Effective date
2019-10-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:07:07

Label at a glance#

ProductInfants Pain and Fever
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

temporarily reduces fever temporarily 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 take more than directed (see overdose warning) shake well before using mL= milliliter only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child remove cap, insert syringe into hole at top of bottle and turn upside down pull back syringe until filled to be pr...

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily reduces fever
  • temporarily 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 non prescription). 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

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 use and ask a doctor if

OTC - STOP USE SECTION

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical 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 take more than directed (see overdose warning)
  • shake well before using
  • mL= milliliter
  • only use the enclosed syringe.

Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child

  • remove cap, insert syringe into hole at top of bottle and turn upside down
  • pull back syringe until filled to be prescribed level. If you pass the prescribed level, simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child's mouth (towards inner cheek)
  • If needed, repeat dose every 4 hours while syptoms last
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor
  • replace cap tightly to maintain child resistance
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age
Weight (lb)Age (year) Dose (mL)* 
under 24  under 2 ask a doctor
 24-35 2-3 5 mL

 *or as directed by a doctor

Other information

SPL UNCLASSIFIED SECTION

  • store between 20-25ºC (68-77ºF)
  • do not refrigerate.
  • see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, butylparaben, carboxymethylcellulose sodium, citric acid, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, propylene glycol, purfied water, sodium benzoate, sorbitol, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ASPIRIN & ALCOHOL FREE

**COMPARE TO THE ACTIVE INGREDIENT IN INFANTS' TYLENOL® ORAL SUSPENSION 

RELIEVES • INFANTS'

Pain and Fever

Acetaminophen 160 mg per 5 mL Oral suspension

Pain reliever / Fever reducer

  • Alcohol free
  • Aspirin free
  • ibuprofen free

For ages 2-3 years

Cherry flavor

Use only enclosed syringe

FL OZ (mL)

**This product is not manufactured or distributed by McNeil Consumer Healthcare,distributor of Infants' Tylenol® Oral Suspension.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE IS BROKEN OR MISSING.

Distributed by:

Rugby Laboratories

 17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RUGBY Infants' Pain & Fever Relief Cherry Flavor
RUGBY Infants' Pain & Fever Relief Cherry Flavor

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1111-96ML - Milliliter0536-1111d4ef7a73-2ec4-4644-bb30-bf9bc966205312016-11-08

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
0536-11110536-1111-96

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 · Source PDF

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
59da470d-75b1-402e-bb64-29e12ea1afad95f5d2a1-8136-4869-bd0f-faace298c34b2020-10-16WarningsExact identifier
spl set id: 95f5d2a1-8136-4869-bd0f-faace298c34b

Reported adverse events (FAERS/openFDA)#

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