OTC Medication Information: Little Fevers by Little Remedies

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.

Drug Facts

Act ive Ingredient

(in each 1.0 mL )

Acetaminophen 80mg

Purpose

Pain Reliever/Fever Reducer

Uses

Temporarily:

  • reduces fever
  • relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or 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.

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
Under24 Under2 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

  • Store at 20-25°C (68-77°F)
  • Oral dosing device enclosed.

  • Tamper Evident: This product has a foil seal under the cap. Do not use if broken or missing.
  • Check expiration date on bottle or box before using.

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)
(click image for full-size original)
LITTLE FEVERS BY LITTLE REMEDIES acetaminophen liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-601
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN .8 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
HIGH FRUCTOSE CORN SYRUP
SODIUM BENZOATE
GLYCERIN
POLYETHYLENE GLYCOL
PROPYLENE GLYCOL
SUCRALOSE
WATER
ANHYDROUS CITRIC ACID
Product Characteristics
Color WHITE Score
Shape Size
Flavor RASPBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63029-601-01 1 BOTTLE, PLASTIC (1 BOTTLE) in 1 BOX contains a BOTTLE, PLASTIC
1 30 mL in 1 BOTTLE, PLASTIC This package is contained within the BOX (63029-601-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part341 07/05/2010
Labeler — Medtech Products Inc. (122715688)

Revised: 07/2010 Medtech Products Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2024. All Rights Reserved.