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Infants Pain and Fever by Rugby Laboratories, Inc.

Dosage form: suspension
Ingredients: ACETAMINOPHEN 160mg in 5mL
Labeler: Rugby Laboratories, Inc.
NDC Code: 0536-1111

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.

Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses
  • temporarily reduces fever
  • temporarily 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
  • 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
  • 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

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
  • 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.

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

Inactive ingredients

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?

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

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

RUGBY Infants' Pain & Fever Relief Cherry Flavor

INFANTS PAIN AND FEVER 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1111
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN 
CARBOXYMETHYLCELLULOSE SODIUM 
ANHYDROUS CITRIC ACID 
FD&C RED NO. 40 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
XANTHAN GUM 
ACESULFAME POTASSIUM 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-1111-961 BOTTLE, PLASTIC in 1 BOX
159 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34304/30/2016
Labeler - Rugby Laboratories, Inc. (079246066)

 
Rugby Laboratories, Inc.

← See all Infants Pain and Fever brands

Medically reviewed on Oct 22, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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