Acetaminophen by Delsam Pharma Llc ACETAMINOPHEN liquid

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Delsam Pharma Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 REACH OF CHILDREN

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

Weight	Age	Dose
under 24 lbs	Under 2 years	ask a doctor
24 to 35 lbs	2 to 3 years	5mL
36 to 47 lbs	4 to 5 years	7.5mL
48 to 59 lbs	6 to 8 years	10mL
60 to 71 lbs	9 to 10 years	12.5mL
72 to 95 lbs	11 years	15mL

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.

SPL UNCLASSIFIED SECTION

Fast, Effective Relief of Children's Fever and Pain

• Alcohol Free
• Aspirin Free
• Cherry Flavor

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

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72570-100
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	red (pinkish red)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72570-100-04	1 in 1 CARTON	09/25/2018
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	09/25/2018

Labeler - Delsam Pharma Llc (081369679)