Acetaminophen by SAMJAN GROUP INC. ACETAMINOPHEN liquid

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by SAMJAN GROUP INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (per 5mL teaspoonful)

Acetaminophen 160 mg

PURPOSE

Pain Reliever / Fever Reducer

Uses

temporarily relieves minor aches 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 taken 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.

Do not use

with any other drug 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 DOCTOR

Ask a doctor before use if your child has a liver disease.

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

WHEN USING

When using this product: Do not exceed recommended dose.

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.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

do not take more than directed

This product does not contain directions or complete warnings for adult use.

find dose in chart below, if possible, use weight to dose, otherwise use age

dosage may be repeated every 4 hours as needed, or as directed by a doctor

do not give more than 5 doses in 24 hours 5 milliliters (mL) = 1 teaspoon

Weight (lb)	Under 24	24-36	36-47	48-59	60-71	72-95
age (yr)	Under 2	2-3	4-5	6-8	9-10	11
Dosage (mL)	ask a doctor	5 mL	7.5 mL	10 mL	12.5 mL	15 mL

Other information

each teaspoonful (5 mL) contains: sodium 7.9 mg

store at room temperature 15°- 30°C (59°-86°F)

protect from freezing protect from light

TAMPER-EVIDENT: Do not use if imprinted seal under cap is broken or missing.

Inactive ingredients:

artificial cherry flavor, citric acid, FD&C Red #40, glycerin, PEG, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol.

PRINCIPAL DISPLAY PANEL

Compare To Active ingredient of Children's Tylenol

NDC 72091-004-01

Children's Liquid

Pain Reliever and Fever Reducer

Acetaminophen 160 mg/5mL

Asprin Free

Alcohol Free

For Children Ages 2 - 11 years

Fruit Flavor

8 FL OZ (237 mL)

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72091-004
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72091-004-01	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/17/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	03/17/2021

Labeler - SAMJAN GROUP INC. (080313200)