LITTLE FEVERS BY LITTLE REMEDIES- acetaminophen liquid 
Medtech Products Inc.

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.

----------

Little Fevers Little Remedies

Drug Facts

Active Ingredient

(in each 1.0 mL)

Acetaminophen 80mg

Purpose

Pain Reliever/Fever Reducer

Uses

Temporarily:

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

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.

Do not use:

  • with any other products 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.

Sore Throat Warning: If sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

When using this product

DO NOT EXCEED RECOMMENDED DOSAGE: taking more than the recommended dose (overdose) may not provide more relief and may cause liver damage.

Stop use and ask a doctor if:

  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • pain gets worse or lasts more than 5 days
  • redness or swelling is present. These could be signs of a serious condition.

Keep out of reach of children.

Overdose

Warning: Taking more than the recommended dose (overdose) can cause serious liver damage. In case of overdose, get medical help or contact a Poison Control Center right away 

(1-800-222-1222). Prompt 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.
  • Shake well before using.
  • Find the right dose on the chart below. (If possible, use weight to dose; otherwise, use age.)
  • Only use the enclosed dropper. Do not use any other dropper, spoon or dosing device when giving this medicine to your child.
  • Fill the enclosed dropper to the prescribed level and slowly dispense the liquid into your child’s mouth (towards the inner cheek).
  • If needed, repeat dose every 4 hours while symptoms last.
  • Do not give more than 5 times in any 24-hour period (see overdose warning).
  • Replace dropper tightly to maintain child resistance.
Weight
(Ibs)
Age
(yrs)
Dose
Under
24
Under
2
Ask a doctor
24-35
2-3
2.0 mL
(1.0 mL + 1.0mL)
36-47
4-5
3.0 mL (1.0mL +
1.0 mL + 1.0mL)

Other Information

Inactive Ingredients:

Citric Acid, Glycerin, High Fructose Corn Syrup, Natural Flavors, PEG, Propylene Glycol, Purified Water, Sodium Benzoate and Sucralose

Questions?

For further information you may contact us at:

1-800-7-LITTLE Mon.-Fri. 8:00 a.m. to 8:00 p.m. EST, or visit us at www.LittleRemedies.com.

©2010 Dist. by: Medtech Products Inc., Irvington, NY 10533, a Prestige Brands Company Made in U.S.A.

LR089101

PRINCIPAL DISPLAY PANEL

MEDICATED FOR INFANTS
Little Fevers ®

by Little Remedies®

NEW!

FEVER/PAIN

RELIEVER

Acetaminophen

SAFE, GENTLE & EFFECTIVE

NATURAL BERRY FLAVOR

SEE NEW WARNINGS INFORMATION.

1 FL. OZ. (30
mL)

PRINCIPAL DISPLAY PANEL
Little Fevers by Little Remedies
1 FL. OZ. (30mL)

LITTLE FEVERS BY LITTLE REMEDIES 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-601
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN.8 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-601-011 in 1 BOX
130 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34107/05/2010
Labeler - Medtech Products Inc. (122715688)

Revised: 7/2010
Document Id: d74cce29-359d-4e1d-9555-83a342d86999
Set id: 5d3857b2-7579-44e4-84d1-24d72c0066b0
Version: 1
Effective Time: 20100702
 
Medtech Products Inc.