CHILDRENS ACETAMINOPHEN PAIN RELIEF- acetaminophen solution 
Bio-Pharm, 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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Children's Acetaminophen
Pain Relief

Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever - Fever reducer

Uses

  • Temporarily relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
  • Temporarily reduces fever

Warnings

Liver warning

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

  • more than 5 doses in 24 hours, which is the 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, 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 nonprescription).
  • If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.
  • 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
  • new symptoms occur
  • redness or swelling is present. 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 (1-800-222-1222) right away.

Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

  • This product does not contain directions or complete warnings for adult use.
  • find right dose on chart. If possible, use weight to dose; otherwise, use age
  • if needed, repeat dose every 4 hours
  • use enclosed dosing cup only
  • do not use more than 5 times in 24 hour
  • mL = milliliter
WeightAgeDose
under 24 lbsunder 2 yearsask a doctor
24 to 35 lbs2 to 3 years5mL
36 to 47 lbs4 to 5 years7.5mL
48 to 59 lbs6 to 8 years10mL
60 to 71 lbs9 to 10 years12.5mL
72 to 95 lbs11 years15mL

Other information

  • each 5mL contains: sodium 1mg
  • store at 20°-25°C(68°-77°F)

Inactive Ingredients

artificial flavor, citric acid anhydrous, D&C Red #33, FD&C Red #40, glycerin, polyethylene glycol 1450, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol.

Questions or comments?

866-845-1611

Manufactured by:
Bio-Pharm, Inc.
Levittown, PA 19057

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 59741-101-06

TAMPER-EVIDENT

ASSURED™

FEVER REDUCER - PAIN RELIEVER

Children's
Acetaminophen
Liquid

4 Fl. OZ. (118 mL) 160mg per 5mL

Fast, Effective Relief of Children's
Fever and Pain

  • Alcohol-Free
  • Ibuprofen-Free
  • Aspirin-Free
  • Cherry-Flavor

COMPARE TO the active
ingredient of TYLENOL®* LIQUID

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
CHILDRENS ACETAMINOPHEN  PAIN RELIEF
acetaminophen solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59741-101
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
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SORBITOL (UNII: 506T60A25R)  
PRUNUS SEROTINA BARK (UNII: 5D48E975HA)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59741-101-06118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/201005/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34308/01/201005/31/2019
Labeler - Bio-Pharm, Inc. (801652546)
Establishment
NameAddressID/FEIBusiness Operations
Bio-Pharm, Inc.801652546MANUFACTURE(59741-101) , ANALYSIS(59741-101) , PACK(59741-101) , LABEL(59741-101)

Revised: 8/2018
Document Id: 74a3d646-0744-483f-9525-afebae0de820
Set id: 666e3e53-d592-471d-8c07-ce6b7a5156fb
Version: 4
Effective Time: 20180824
 
Bio-Pharm, Inc.