RESFRIOL-ITO CHILDREN- acetaminophen tablet, chewable

Resfriol-ito Children by

Drug Labeling and Warnings

Resfriol-ito Children by is a Otc medication manufactured, distributed, or labeled by OPMX LLC, HBC HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each chewable tablet)

• Acetaminophen 160 mg

Purposes

• Pain reliever/ Fever reducer

Uses

Termporarily relieves minor aches and pains due to:

• Headache
• Toothache
• Flu
• Sore throat
• The common cold
• 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 redding
• 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 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 a doctor or pharmacist before use if your child is

taking the blood thinning drug warfaron.

When using this product do not exceed recommended dosage.

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

Stop use and ask a doctor if

• Pain gets worse or lasts more than 5 days
• Fever gets worse or lasts more the 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 reach of children.

In case of overdose, get medical help or contact a Posin Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symtoms.

Directions

• This product does not contain directions or complete warnings for adult use.
• Do not give more than directed.
• Find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
• Chew or crush tablets completely before swallowing; do not swallow tablets whole.
• Repeat dose every 4 hours while symptoms last.
• Do not give more than 5 times in 24 hours.
• Do not give for more than 5 days unless directed by a doctor.

*or as directed by a doctor

Other information

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• Avoid high humidity
• Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• See and flap for expiration date and lot number

Inactive ingredients

Citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose.

Questions or comments?

Call (619)600-5632 (Mon-Fri 9am - 5pm PST)

SPL UNCLASSIFIED SECTION

Exclusively distributed by:

OPMX

Chula Vista, CA 91910

Phone: 619-600-5632

PRINCIPAL DISPLAY PANEL

NDC: 69729-161-24

RESFRIOL-ITO®

Children

Acetaminophen 160 mg

2-11

YEARS/AÑOS

Auxiliar en el alivio del DOLOR Y FIEBRE

Pain Reliever / Fever Reducer

• Aspirin Free / Sin Aspirina
• Ibuprofen Free / Sin ibuprofeno

​Sabor Uva

Grape Flavor

24 Tabletas Masticables Chewable Tablets

INGREDIENTS AND APPEARANCE

RESFRIOL-ITO CHILDREN 
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69729-161
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
ETHYLCELLULOSE (UNII: 7Z8S9VYZ4B)
CITRIC ACID (UNII: 2968PHW8QP)
D&C RED NO. 30 ALUMINUM LAKE (UNII: GE75M6YV5W)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSPOVIDONE (UNII: 2S7830E561)
POLYETHYLENE (UNII: UG00KM4WR7)
SUCRALOSE (UNII: 96K6UQ3ZD4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
DEXTRATES (UNII: G263MI44RU)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
MANNITOL (UNII: 3OWL53L36A)

Product Characteristics
Color	purple (Light purple/pink)	Score	no score
Shape	OVAL (Oblong)	Size	17mm
Flavor	GRAPE	Imprint Code	OPMX
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69729-161-24	2 in 1 CARTON	01/30/2026
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	01/30/2026

Labeler - OPMX LLC (029918743)

Establishment
Name	Address	ID/FEI	Business Operations
HBC HEALTHCARE PRIVATE LIMITED		854255181	manufacture(69729-161)