FDA Label for Little Fevers By Little Remedies
View Indications, Usage & Precautions
Little Fevers By Little Remedies Product Label
The following document was submitted to the FDA by the labeler of this product Medtech Products Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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)
* Please review the disclaimer below.