American Sales Company Infants’ Acetaminophen 160mg Per 5ml Drug Facts

American Sales Company Infants’ Acetaminophen 160mg Per 5ml Drug Facts
SPL v24
SPL
SPL Set ID 7ca92d3f-7240-4a7b-a8ec-f4040c5b6ce8
Route
ORAL
Published
Effective Date 2024-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Anhydrous Citric Acid Calcium Sulfate, Unspecified Form Carrageenan Glycerin Microcrystalline Cellulose Carboxymethylcellulose Sodium, Unspecified Propylene Glycol Water Sodium Benzoate Sorbitol Solution Sucralose Sodium Phosphate, Tribasic Hydroxyethyl Cellulose, Unspecified

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-12-14

Description

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 160 mg

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 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.

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 right dose on chart. If possible, use weight to dose; otherwise, use age.
  • push air out of syringe. Insert syringe tip into bottle opening.
  • flip bottle upside down. Pull yellow part of syringe to the first dose line and then push product back into bottle.
  • pull yellow part of syringe until it reaches and stays at the correct dose
  • dispense liquid slowly into child’s mouth, toward inner cheek
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • replace cap tightly to maintain child resistance

Dosing Chart

Weight (lb)

Age (yr)

Dose (mL)*

under 24

under 2 years

ask a doctor

24-35

2-3 years

5 mL

* or as directed by a doctor

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

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 has ever had an allergic reaction to this product or any of its ingredients
Other Information
  • store at 20-25°C (68-77°F)
  • do not use if printed neckband is broken or missing
Inactive Ingredients

anhydrous citric acid, calcium sulfate, carrageenan, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate

Questions Or Comments?

1-800-719-9260

When Using This Product

do not exceed recommended dose (see overdose warning)

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.

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

Active Ingredient (in Each 5 Ml)

Acetaminophen 160 mg

Package/label Principal Display Panel

CAREone®

Compare to the active ingredient in Infants’ Tylenol® Oral Suspension

For Ages 2 to 3 Years

Infants’

ACETAMINOPHEN 160mg PER 5mL

Pain Reliever/Fever Reducer

Suspension Liquid

Alcohol Free

Aspirin Free

Ibuprofen Free

Dye Free

Gluten Free

Use only with enclosed syringe.

See side panel for more information.

Cherry Flavor

2 FL OZ (59mL)

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


Structured Label Content

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to:
  • the common cold
  • flu
  • headache
  • sore throat
  • toothache
Purpose

Pain reliever/fever reducer

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.

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 right dose on chart. If possible, use weight to dose; otherwise, use age.
  • push air out of syringe. Insert syringe tip into bottle opening.
  • flip bottle upside down. Pull yellow part of syringe to the first dose line and then push product back into bottle.
  • pull yellow part of syringe until it reaches and stays at the correct dose
  • dispense liquid slowly into child’s mouth, toward inner cheek
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • replace cap tightly to maintain child resistance

Dosing Chart

Weight (lb)

Age (yr)

Dose (mL)*

under 24

under 2 years

ask a doctor

24-35

2-3 years

5 mL

* or as directed by a doctor

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

Do Not Use (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 has ever had an allergic reaction to this product or any of its ingredients
Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • do not use if printed neckband is broken or missing
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, calcium sulfate, carrageenan, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate

Questions Or Comments? (Questions or comments?)

1-800-719-9260

When Using This Product (When using this product)

do not exceed recommended dose (see overdose warning)

Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

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

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Acetaminophen 160 mg

Package/label Principal Display Panel (Package/Label Principal Display Panel)

CAREone®

Compare to the active ingredient in Infants’ Tylenol® Oral Suspension

For Ages 2 to 3 Years

Infants’

ACETAMINOPHEN 160mg PER 5mL

Pain Reliever/Fever Reducer

Suspension Liquid

Alcohol Free

Aspirin Free

Ibuprofen Free

Dye Free

Gluten Free

Use only with enclosed syringe.

See side panel for more information.

Cherry Flavor

2 FL OZ (59mL)

Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)

liver disease

Ask A Doctor Or Pharmacist Before Use If Your Child Is (Ask a doctor or pharmacist before use if your child is)

taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)