CHILDRENS PAIN RELIEF- acetaminophen liquid 
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 Pain Relief

Drug Facts

Active ingredient (in each TSP (5 mL))

Acetaminophen 160 mg

Purpose

Pain reliever - Fever reducer

Uses

  • temporarily reduce fever
  • for the temporary relief of minor aches and pains associated with
  • a common cold
  • flu
  • sore throat
  • headache
  • toothache

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.

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.

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.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of the 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 needed, repeat dose every 4 hours
  • use enclosed dosing cup only
  • if possible, use weight to dose; otherwise, use age
  • do not use more than 5 times in 24 hour
WeightAgeDose
under 24 lbsunder 2 yearsask a doctor
24 to 35 lbs2 to 3 years1 TSP
36 to 47 lbs4 to 5 years1 1/2 TSP
48 to 59 lbs6 to 8 years2 TSP
60 to 71 lbs9 to 10 years2 1/2 TSP
72 to 95 lbs11 years3 TSP

Other information

  • each TSP (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, sodium benzoate, sodium saccharin, sorbitol

Questions or comments?

866-845-1611

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 59741-246-04

Tamper-Evident

For Ages 2-11

BIO-PHARM

Children's
Pain Relief

Oral Solution
Acetaminophen
Fever Reducer / Pain Reliever

Cherry Flavor

  • Alcohol Free
  • Aspirin Free
  • Ibuprofen Free
  • Sugar Free

4 FL OZ (118 mL)
160 mg per 5 mL

See new warnings information

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
CHILDRENS PAIN RELIEF 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59741-246
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 1450 (UNII: OJ4Z5Z32L4)  
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:59741-246-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/20/201502/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34302/20/201502/28/2017
Labeler - Bio-Pharm, Inc. (801652546)
Establishment
NameAddressID/FEIBusiness Operations
Bio-Pharm, Inc.801652546MANUFACTURE(59741-246) , ANALYSIS(59741-246) , PACK(59741-246) , LABEL(59741-246)

Revised: 8/2018
 
Bio-Pharm, Inc.