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NDC 60577-0974-09 Infants Nanomol Dye-Free Cherry 160 mg/5mL Details

Infants Nanomol Dye-Free Cherry 160 mg/5mL

Infants Nanomol Dye-Free Cherry is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Vitane Pharmaceutical 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: 60577-0974-09
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	60577-0974
Product ID	60577-974_b27ffc07-347b-4ad0-8322-3f74d31a5e86
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Infants Nanomol Dye-Free Cherry
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acteaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	160
Active Ingredient Units	mg/5mL
Substance Name	ACETAMINOPHEN
Labeler Name	Vitane Pharmaceutical Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	2022-12-31

Package

Package Images

NDC 60577-0974-09 (60577097409)

Pricing Information	N/A
NDC Package Code	60577-974-09
Billing NDC	60577097409
Package	1 BOTTLE in 1 PACKAGE (60577-974-09) / 30 mL in 1 BOTTLE
Marketing Start Date	2016-06-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 095305d9-391f-412e-8683-db1fc1208501 Details

Active ingredients (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

SPL UNCLASSIFIED SECTION

Uses

temporarily:

reduces fever

relieves minor aches and pains due to:

the common cold

sore throat

flu

toothache

headache

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes:

more than 5 doses in 24 hours, which is 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, or 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 non prescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
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 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
redness or swelling is present

new symptoms occur

These could be signs of a serious condition.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a poison control center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

this product does not contain directions or complete warnings for adult dose
do not give more than directed (see overdose warning)
shake well before use
use only enclosed dosing syringe
find the right dose on chart below
remove cap and insert syringe, invert the bottle and draw the liquid to the prescribed level.
dispense liquid slowly into childs mouth towards inner cheek
repeat dose every 4 hours if needed
do not give more than 5 times in 24 hours
replace the cap tightly to maintain child resistance
return the dispenser to the box after thorough cleaning
mL=milliliter

Dosing Chart
WEIGHT (lb)	AGE (yr)	DOSE (mL)*
under 24	under 2 years	ask a doctor
24-35	2-3 years	5mL

*or as directed by a doctor

Other information

store between 20-25oC(68-77oF)

Inactive ingredients

butyl paraben, citric acid, flavor, glycerin, maltitol, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propyl paraben, purified water, sucralose, xanthan gum

PDP

*Compare to the active ingredient in Infants TYLENOL®Suspension

Infants Nanomol Dye free Fever & Pain Reliever

Cherry Flavor Oral Suspension Liquid

Acetaminophen

Pain reliever/Fever reducer

For Ages 2-3 Years

Non-staining

Alcohol Free

Aspirin Free

Ibuprofen Free

1 FL OZ (30 mL) 160 mg per 5 mL

INGREDIENTS AND APPEARANCE

INFANTS NANOMOL DYE-FREE CHERRY

acteaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60577-974
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
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:60577-974-09	1 in 1 PACKAGE	06/06/2016
1		30 mL in 1 BOTTLE; 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	06/06/2016

Labeler - Vitane Pharmaceutical Inc. (029029638)

Registrant - Guardian Drug Company (119210276)

Name	Address	ID/FEI	Business Operations
Establishment
Guardian Drug Company		119210276	manufacture(60577-974)

Revised: 8/2016

Document Id: b27ffc07-347b-4ad0-8322-3f74d31a5e86

Set id: 095305d9-391f-412e-8683-db1fc1208501

Version: 1

Effective Time: 20160816