CHILDRENS ACETAMINOPHEN- childrens acetaminophen oral suspension

CHILDRENS ACETAMINOPHEN by

Drug Labeling and Warnings

CHILDRENS ACETAMINOPHEN by is a Otc medication manufactured, distributed, or labeled by AARNA USA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Active ingredient(in each 5mL)                                             Purpose
Acetaminophen 160 mg ………………………….........Pain reliever/fever reducer

Uses

temporarily: reduces fever

relieves minor aches and pains due to:

• the common cold
• flu
• headache
• sore throat
• toothache

Warnings

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

• more then 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, persist or 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 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 anyof the inactive ingredients in this product.

Ask a doctor or pharmacist before use if the child has

liver disease.

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

Overdose warning:

In case of overdose, get medical help to contact Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Keep out of Reach of children

Directions

• This product does not contain directions or complete warnings

for adult use

• do not give more than directed (see overdose warning)
• shake well before using
• mL=milliliter
• find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
• repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours

Weight (lbs.)	Age (yrs.)	Dose (tsp or mL)
under 24	under 2	ask a doctor
24 to 35	2 to 3	1 tsp or 5 mL
36 to 47	4 to 5	1 1/2 tsp or 7.5 mL
48 to 59	6 to 8	2 tsp or 10 mL
60 to 71	9 to 10	2 1/2 tsp or 12.5 mL
72 to 95	11	3 tsp or 15 mL

*or as directed by a doctor

• Attention: use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.

Other Information

• Store at room temperature 20°-25°C (68°-77°F). Protect from freezing. Protect from light.

Inactive Ingredients

Anhydrous Citric Acid, D&C Red #33, FD&C Blue #1, Grape Flavor, Glycerin, Microcrystalline cellulose and Sodium Methyl Cellulose, Potassium Sorbate, Purified Water, Sorbitol, Sucralose, Sucrose, Xanthan gum.

Questions or comments?

Call toll-free 1-877-225-6999

Manufactured for:

AARNA USA INC.

Leland, NC-28451

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHILDRENS ACETAMINOPHEN 
childrens acetaminophen oral suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82568-0010
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82568-0010-2	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2025
2	NDC: 82568-0010-4	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2025
3	NDC: 82568-0010-8	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2025
4	NDC: 82568-0010-6	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	06/20/2025

Labeler - AARNA USA INC. (118515992)