LITTLE FEVERS INFANT GRAPE FEVER/PAIN RELIEVER- acetaminophen liquid

Little Fevers Infant Grape Fever/Pain Reliever by

Drug Labeling and Warnings

Little Fevers Infant Grape Fever/Pain Reliever 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 5.0 mL)

Acetaminophen 160mg

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.

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

Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
  
• blisters
  
• rash.

If skin reaction occurs, stop use and seek medical help right away.

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.

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.

When using this product

do not exceed recommended dosage (see overdose warning.)

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 (1-800-222-1222) immediately. 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 determine dose; otherwise, use age.)
  
• Only use the enclosed AccuSafeTM syringe
  
• Remove cap, insert syringe to flow restrictor and invert bottle
  
• Pull back syringe until filled to prescribed level and slowly dispense the liquid into your child’s mouth (toward 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 cap tightly to maintain child resistance.

mL = mililiter

Weight (lbs)	Age (yrs)	Dose
Under 24	Under 2	Ask a doctor
24-35	2-3	5 mL

Other information

• Store at 20-25ºC (68-77ºF)
  
• AccuSafeTM dosing device enclosed
  
• Check expiration date on bottle or box before using

Inactive ingredients

citric acid, glycerin, natural grape flavor, potassium sorbate, povidone, propylene glycol, purified water, sodium citrate, sucralose, sucrose, xanthan gum

Questions?

1-800-54-8853 Mon. – Fri. 8:00 a.m.to 8:00 p.m. EST 

LittleRemedies.com

PRINCIPAL DISPLAY PANEL

Little Remedies®
INFANT

FEVER + PAIN RELIEVER
Acetaminophen 160 mg / 5 mL

natural grape flavor
2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

LITTLE FEVERS INFANT GRAPE FEVER/PAIN RELIEVER 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-611
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-611-01	1 in 1 BOX	07/01/2011
1		1 in 1 BOX
1		59 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	07/01/2011

Labeler - Medtech Products Inc. (122715688)