ACETAMINOPHEN- acetaminophen liquid 
Delsam Pharma Llc

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.

----------

Acetaminophen LIQUID

Drug Facts

Active ingredient (in each 5mL)

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 last for more than 5 days
• fever gets worse or last for more than 3 days
• new symptoms occur • redness or swelling is present
These could be signs of a serious condition.

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 for adults as well as children 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
• mL = milliliter
• if needed, repeat dose every 4 hours
• do not use more than 5 doses in 24 hours
• use enclosed dosing cup only. Do not use any other device

WeightAge Dose
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

Inactive ingredients

artificial flavour, Methylparaben, Propylparaben, Potassium sorbate, Citric Acid Monohydrate, Sorbitol, Propylene glycol, Sucralose, Povidone K30, Glycerin, FD&C Red #40, D&C Red #33 & Purified water.

Other information

• TAMPER EVIDENT: Do not use this product if inner foil seal over mouth of the bottle is cut, torn, broken, or missing.

• store at 20°- 25°C (68° - 77°F)

• this product is not the same concentration as Infants' Drops. For accurate dosing, follow the dosing instructions on this label.

Questions or Comments?

1-866-826-1306 between 9 am and 4 pm EST, Monday- Friday.

Fast, Effective Relief of Children's Fever and Pain

DOSAGE CUP ENCLOSED

​COMPARE TO the active ingredient of TYLENOL®*LIQUID

TAMPER EVIDENT

Child-Resistant Safety Cap Unbreakable Bottle

* Delsam Pharma Llc is not affiliated with the owner of the registered trademark Tylenol®

Distributed by

Delsam Pharma Llc

Bronx, Newyork 10467

Packaging

Acetaminop-1

ACETAMINOPHEN 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72570-100
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
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SORBITOL (UNII: 506T60A25R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
POVIDONE K30 (UNII: U725QWY32X)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorred (pinkish red) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72570-100-041 in 1 CARTON09/25/2018
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/25/2018
Labeler - Delsam Pharma Llc (081369679)

Revised: 9/2018
Document Id: d48e286c-5a69-4bc9-a9d0-7a28c31869bc
Set id: 61766b7f-bd8d-4511-b12e-6470dca0d849
Version: 1
Effective Time: 20180924
 
Delsam Pharma Llc