Little Fevers By Little Remedies
FDA Label NDC 63029-601

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Little Fevers By Little Remedies (NDC 63029-601). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, ask a doctor before use, ask a doctor or pharmacist before use, do not use:, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active 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.

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

  • 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 Panellittle Fevers By Little Remedies1 Fl. Oz. (30ml) (Little Fevers Little Remedies 01)

Principal Display Panellittle Fevers By Little Remedies1 Fl. Oz. (30ml) (Little Fevers Little Remedies 01)

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