INFANTS NANOMOL DYE-FREE CHERRY- acteaminophen suspension

Infants Nanomol Dye-Free Cherry by

Drug Labeling and Warnings

Infants Nanomol Dye-Free Cherry by is a Otc medication manufactured, distributed, or labeled by Vitane Pharmaceutical Inc., Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

KEEP OUT OF REACH OF CHILDREN

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

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
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	06/06/2016

Labeler - Vitane Pharmaceutical Inc. (029029638)

Registrant - Guardian Drug Company (119210276)

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