CHILDRENS NANOMOL DYE-FREE CHERRY- acteaminophen suspension 
Vitane Pharmaceutical Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Childrens Nanamol Dye-Free Fever & Pain Reliever Cherry Flavor Oral Suspension

Active ingredients (in each 5 mL teaspoon)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

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 years3tsp           

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)

BOX

CHILDRENS NANOMOL DYE-FREE CHERRY 
acteaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60577-574
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60577-574-031 in 1 CARTON08/17/201609/20/2023
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/17/201609/20/2023
Labeler - Vitane Pharmaceutical Inc. (029029638)
Registrant - Guardian Drug Company (119210276)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276manufacture(60577-574)

Revised: 9/2023
 
Vitane Pharmaceutical Inc.