ACETAMINOPHEN- acetaminophen suspension 
Healthlife of USA

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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Infant's Acetaminophen Oral SuspensionPain Reliever/ Fever Reducer

Drug Facts

Active ingredient (in each 5mL)

Acetaminophen 160mg

Purpose

Fever reducer/ pain reliever

Uses

Temporarily:

  1. reduces fever
  2. relieves minor aches and pains due to:

Warnings

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

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.

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

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

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Weight (lb)Age (year)Dose (mL)*
Under 24Under 2 years Ask a doctor
24-352-35mL

* or as directed by a doctor

Attention: Use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

Other information

Inactive ingredients

Acesulfame Potassium, Avicel, Butyl paraben, citric acid, FD&C Red #40, Glycerin, High fructose corn syrup, Nat grape flavor, polysorbate 80, propylene glycol, sodium benzoate, sorbitol, sucralose, Prosweet N and A, Purified water, xanthan gum

Questions or comments?

Call 1-844-832-1138

Infant's Acetaminophen Oral Suspension
Pain Reliever/ Fever Reducer

Distributed by:

Healthlife of USA

1600 Hart Street,

Rahway, NJ 07065

www.healthlifeofusa.com

image description

ACETAMINOPHEN 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-627
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
water (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69517-627-171 in 1 CARTON01/10/2018
115 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 finalpart34301/10/2018
Labeler - Healthlife of USA (079656178)
Establishment
NameAddressID/FEIBusiness Operations
Kingston Pharma LLC080386521manufacture(69517-627)

Revised: 1/2018
Document Id: a006562d-548e-445c-98a3-4dc8b1c62617
Set id: c2c36840-8980-4b23-99fc-13f9471b2064
Version: 1
Effective Time: 20180110
 
Healthlife of USA