CHILDRENS NANOMOL DYE-FREE CHERRY- acteaminophen suspension

Childrens Nanomol Dye-Free Cherry by

Drug Labeling and Warnings

Childrens 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 teaspoon)

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 alery: 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 product 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

taking the blood thinning drug warfarin

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

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

Weight(lb)	Age(yr)	Dose (mL)
under 24 lbs	under 2 years	ask a doctor
24-35 lbs	2-3 years	1 tsp
36-47 lbs	4-5 years	11/2 tsp
48 - 59 lbs	6-8 years	2 tsp
60 - 71 lbs	9-10 years	21/2 tsp
72 - 95 lbs	11 years	3tsp

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 childrens liquid tylenol

Childrens Nanomol

Dye-free Fever & Pain Reliever

Cherry Flavor

Oral suspension liquid

Acetaminophen 160mg /5mL

Fever reducer / Pian reliever

For ages 2-11 years

Non-staining

alcohol free

aspirin free

ibuprofen free

4 fl oz (118 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS NANOMOL DYE-FREE CHERRY 
acteaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60577-574
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: 60577-574-03	1 in 1 CARTON	08/17/2016
1		118 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	08/17/2016

Labeler - Vitane Pharmaceutical Inc. (029029638)

Registrant - Guardian Drug Company (119210276)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	manufacture(60577-574)