DYE FREE CHILDRENS ACETAMINOPHEN- acetaminophen suspension

Dye Free Childrens Acetaminophen by

Drug Labeling and Warnings

Dye Free 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

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 a 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 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)

Inactive ingredients

anhydrous citric acid, calcium sulfate, carrageenan, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate

SPL UNCLASSIFIED SECTION

Alcohol Free, Aspirin Free, Dye Free, Gluten Free, Ibuprofen Free

Questions or comments?

1-800-397-9228

How Supplied

NDC: 68094-061-61
5 mL per unit dose cup
One hundred (100) cups per shipper

NDC: 68094-061-62
5 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

QUESTIONS

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com

SPL UNCLASSIFIED SECTION

LI1531 Rev. 02/23

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

NDC: 68094-061-59

PrecisionDose™

Children's ACETAMINOPHEN
Oral Suspension, 160 mg/5 mL

Dye
Free

Pkg: Precision Dose, Inc., S. Beloit, IL 61080

INGREDIENTS AND APPEARANCE

DYE FREE CHILDRENS ACETAMINOPHEN 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68094-061(NDC:0113-8959)
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)
CALCIUM SULFATE, UNSPECIFIED FORM (UNII: WAT0DDB505)
CARRAGEENAN (UNII: 5C69YCD2YJ)
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)

Product Characteristics
Color	WHITE ((opaque, viscous))	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68094-061-62	3 in 1 CASE	08/02/2022
1		10 in 1 TRAY
1	NDC: 68094-061-59	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 68094-061-61	10 in 1 CASE	08/02/2022
2		10 in 1 TRAY
2	NDC: 68094-061-59	5 mL in 1 CUP, UNIT-DOSE; 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	08/02/2022

Labeler - Precision Dose Inc. (035886746)