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NDC 68094-0015-62 Dye Free Childrens Acetaminophen 160 mg/5mL Details

Dye Free Childrens Acetaminophen 160 mg/5mL

Dye Free Childrens Acetaminophen is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Precision Dose, Inc.. The primary component is ACETAMINOPHEN.

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 68094-0015-62
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	68094-0015
Product ID	68094-015_b356b25c-c430-49a8-b4b0-fb7937bf1bcb
Associated GPIs	64200010001840
GCN Sequence Number	065752
GCN Sequence Number Description	acetaminophen ORAL SUSP 160 MG/5ML ORAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	27794
HICL Sequence Number	001866
HICL Sequence Number Description	ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	Dye Free Childrens Acetaminophen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	160
Active Ingredient Units	mg/5mL
Substance Name	ACETAMINOPHEN
Labeler Name	Precision Dose, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	2024-12-31

Package

Package Images

NDC 68094-0015-62 (68094001562)

Pricing Information	N/A
NDC Package Code	68094-015-62
Billing NDC	68094001562
Package	3 TRAY in 1 CASE (68094-015-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-015-59)
Marketing Start Date	2017-01-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 86961ee1-7f04-4bb6-a9a0-0337f7978122 Details

SPL UNCLASSIFIED SECTION

Grape Flavor

160 mg/5 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 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, calcium sulfate, carrageenan, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propylparaben, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate

SPL UNCLASSIFIED SECTION

Alcohol Free

Aspirin Free

Dye Free, Non-Staining

Gluten Free

Ibuprofen Free

How Supplied

NDC 68094-015-61

5 mL per unit dose cup

One hundred (100) cups per shipper

NDC 68094-015-62

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

LI1091 Rev. 03/17

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

NDC 68094-015-59

PrecisionDose™

Children's ACETAMINOPHEN

Oral Suspension

160 mg/5 mL

DYE

FREE

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

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

INGREDIENTS AND APPEARANCE

DYE FREE CHILDRENS ACETAMINOPHEN

acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68094-015(NDC:0113-0397)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
anhydrous citric acid (UNII: XF417D3PSL)
calcium sulfate, unspecified form (UNII: WAT0DDB505)
carrageenan (UNII: 5C69YCD2YJ)
glycerin (UNII: PDC6A3C0OX)
microcrystalline cellulose (UNII: OP1R32D61U)
carboxymethylcellulose sodium, unspecified form (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	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68094-015-62	3 in 1 CASE	01/13/2017
1		10 in 1 TRAY
1	NDC:68094-015-59	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC:68094-015-61	10 in 1 CASE	08/17/2017
2		10 in 1 TRAY
2	NDC:68094-015-59	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part343	01/13/2017

Labeler - Precision Dose, Inc. (035886746)

Revised: 11/2020

Document Id: b356b25c-c430-49a8-b4b0-fb7937bf1bcb

Set id: 86961ee1-7f04-4bb6-a9a0-0337f7978122

Version: 3

Effective Time: 20201112

Search by Drug Name or NDC

NDC 68094-0015-62 Dye Free Childrens Acetaminophen 160 mg/5mL Details

Dye Free Childrens Acetaminophen 160 mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 68094-0015-62 (68094001562)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 86961ee1-7f04-4bb6-a9a0-0337f7978122 Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each 5 mL)

Purpose

Uses

Warnings

Liver warning

Allergy alert

Sore throat warning

Do not use

Stop use and ask a doctor if

Overdose warning

Directions

Other information

Inactive ingredients

SPL UNCLASSIFIED SECTION

How Supplied

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

INGREDIENTS AND APPEARANCE

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