LITTLE REMEDIES CHILDRENS FEVER PAIN RELIEVER- acetaminophen liquid

Little Remedies Childrens Fever Pain Reliever by

Drug Labeling and Warnings

Little Remedies Childrens 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 mL)

Acetaminophen 160 mg

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.

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.

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.

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 the 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 right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs of symptoms.

Directions

This product does not contain directions or complete warnings for adult use.

• Do not give more than directed (see overdose warning).
• Shake well before using.
• Find the right dose on the chart below. (If possible, use weight to determine dosing; otherwise, use age.)
• Pour liquid into AccuSafe® dosing cup to the appropriate amount for your child's weight and/or age.
• Only use with enclosed AccuSafe® dosing cup.
• If needed, repeat dose every 4 hours while symptoms last.
• Do not give more than 5 days in any 24-hour period (see overdose warning).
• Do not give more than 5 days unless directed by a doctor.
• Replace cap tightly to maintain child resistance.

Weight (lb)	Age (yr)	Dose
Under 24	under 2	Ask a doctor
24-35	2 – under 4	5mL
36-47	4 – under 6	7.5mL
48-59	6 – under 9	10 mL
60-71	9 – under 11	12.5mL
72-95	11 – under 12	15mL

Other information

• Store at 20-25ºC (68-77ºF)
• AccuSafe® Dosing cup enclosed.
• Check expiration date on bottle or box before using.
• Tamper Evident: DO NOT USE if printed shrink band on bottle is broken or missing.

Inactive ingredients

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

Questions?

1-800-754-8853

Mon. – Fri. 8:00 a.m. to 8:00 p.m. EST   LittleRemedies.com.

Principal Display Panel

Little Remedies®
CHILDREN’S FEVER + PAIN RELIEVER
Acetaminophen
NATURAL CHERRY FLAVOR
4 FL OZ (118 mL)

Principal Display Panel

Little Remedies®
CHILDREN’S FEVER + PAIN RELIEVER
Acetaminophen
NATURAL GRAPE FLAVOR
4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

LITTLE REMEDIES CHILDRENS FEVER PAIN RELIEVER 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-602
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		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-602-02	1 in 1 CARTON	09/01/2010
1		118 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	09/01/2010

LITTLE REMEDIES CHILDRENS FEVER PAIN RELIEVER 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-603
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		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-603-02	1 in 1 CARTON	09/01/2010
1		118 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	09/01/2010

Labeler - Medtech Products Inc. (122715688)