LITTLE FEVERS BY LITTLE REMEDIES- acetaminophen liquid

Little Fevers by Little Remedies by

Drug Labeling and Warnings

Little Fevers by Little Remedies by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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.

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

• 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)

INGREDIENTS AND APPEARANCE

LITTLE FEVERS BY LITTLE REMEDIES 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-601
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	.8 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-601-01	1 in 1 BOX
1		30 mL in 1 BOTTLE, PLASTIC

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)