CHILDRENS ACETAMINOPHEN- acetaminophen suspension

Childrens Acetaminophen by

Drug Labeling and Warnings

Childrens Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Precision Dose Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Grape Flavor

80 mg/2.5 mL   160 mg/5 mL   325 mg/10.15 mL

For Hospital Use Only

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 due to:
  • the common cold
  • flu
  • headache
  • sore throat
  • 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 a 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, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if your child has ever had an allergic reaction to this product or any of its ingredients

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 dose (see overdose warning)

Stop use and ask a doctor if

• pain gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

These could be signs of a serious condition.

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

• use as directed per healthcare professional
• this product does not contain directions or complete warnings for adult use
• do not give more than directed (see overdose warning)
• shake cups well before using
• mL = milliliter
• find right dose on chart below. If possible, use weight to dose; otherwise use age.
• repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (mL)*
* or as directed by a doctor
under 24	under 2 years	ask a doctor
24-35	2-3 years	5 mL
36-47	4-5 years	7.5 mL
48-59	6-8 years	10 mL
60-71	9-10 years	12.5 mL
72-95	11 years	15 mL

Other information

• each 5 mL contains: sodium 3 mg
• store at 20-25°C (68-77°F)
• see individual label or shipper for lot number and expiration date

Inactive ingredients

anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate

SPL UNCLASSIFIED SECTION

Alcohol Free, Aspirin Free, Gluten Free, Ibuprofen Free

How Supplied

NDC: 68094-586-58
2.5 mL per unit dose syringe
Fifty (50) syringes per shipper

NDC: 68094-587-58
5 mL per unit dose syringe
Fifty (50) syringes per shipper

NDC: 68094-587-61
5 mL per unit dose cup
One hundred (100) cups per shipper

NDC: 68094-587-62
5 mL per unit dose cup
Thirty (30) cups per shipper

NDC: 68094-588-62
10.15 mL per unit dose cup
Thirty (30) cups per shipper

SPL UNCLASSIFIED SECTION

Distributed By
Perrigo Company
Allegan, MI 49010

Packaged By
Precision Dose, Inc.
South Beloit, IL 61080

LI950 Rev. 03/17

PRINCIPAL DISPLAY PANEL - 2.5 mL Syringe Label

Children's ACETAMINOPHEN
Oral Suspension

80 mg / 2.5 mL Delivers 2.5 mL

Store at 20°-25°C (68°-77°F)
Hospital Use Only
Alcohol Free Aspirin Free
Gluten Free Ibuprofen Free

For Oral Use Only

INGREDIENTS AND APPEARANCE

CHILDRENS ACETAMINOPHEN 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68094-586(NDC:0113-0212)
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
anhydrous citric acid (UNII: XF417D3PSL)
butylparaben (UNII: 3QPI1U3FV8)
CALCIUM SULFATE, UNSPECIFIED FORM (UNII: WAT0DDB505)
carrageenan (UNII: 5C69YCD2YJ)
D&C red NO. 33 (UNII: 9DBA0SBB0L)
FD&C blue NO. 1 (UNII: H3R47K3TBD)
glycerin (UNII: PDC6A3C0OX)
high fructose corn syrup (UNII: XY6UN3QB6S)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sorbitol (UNII: 506T60A25R)
sodium phosphate, tribasic (UNII: A752Q30A6X)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68094-586-58	50 in 1 CASE	07/30/2014
1		1 in 1 BAG
1		2.5 mL in 1 SYRINGE, PLASTIC; 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	07/30/2014

Labeler - Precision Dose Inc. (035886746)