Infants' Oral Suspension

Infants' Oral Suspension
SPL v2
SPL
SPL Set ID a3031139-4709-43f2-95a8-89840c595f7f
Route
ORAL
Published
Effective Date 2024-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Acesulfame Potassium Microcrystalline Cellulose Citric Acid Monohydrate Fd&c Blue No. 1 Glycerin High Fructose Corn Syrup Polysorbate 20 Propylene Glycol Water Sodium Benzoate Sucralose Sorbitol Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-01

Description

Acetaminophen 160 mg ............... Pain reliever/fever reducer

Purpose

Acetaminophen 160 mg ............... Pain reliever/fever reducer


Medication Information

Purpose

Acetaminophen 160 mg ............... Pain reliever/fever reducer

Description

Acetaminophen 160 mg ............... Pain reliever/fever reducer

Section 34088-5

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 right away 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 42229-5

"This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark Tylenol®

Distributed by C.D.M.A. lnc.

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Question: 800-935-2362

Section 50565-1

Keep out of reach of children.

Section 50568-5

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

Section 50569-3

Ask a doctor before use if your child has liver disease

Section 55105-1
  • 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.

When using this product do not  exceed recommended dose (see  overdose warning)

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 below.

If possible, use weight to dose; otherwise, use age.

  • only use enclosed measuring syringe
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours

    Weight (Ib)

    Age (yr)

    Dose (mL)

    or as directed by doctor

    Under 24

    Under 2 years

    Ask a doctor

    24-35

    2-3 years

    5 mL

Do Not Use
  • with any other drug containing acetaminophen (prescription or non-prescription). 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
Other Information
  • store between 20° -25°c (68°-77 °F)
  • protect from freezing
  • protect from light

Questions or comments?

1-800-935-2362 (Mon-Fri 9am-5pm EST)

Uses Temporarily:
  • reduces fever
  • relieves minor aches and pains

due to:



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

acesulfame potassium, avicel, citric acid, FD&C blue no. 1, FD&C red no. 33, flavor, glycerine, high fructose corn syrup, polysorbate, propylene glycol, prosweet N & AK, purified water, sodium benzoate, sucralose, sorbitol, xanthan gum

Principal Display Panel

Stop Use and Ask A Doctor If
  • new symptoms occur 
  • redness or swelling is present
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

Active Ingredient                         purpose

Acetaminophen 160 mg ............... Pain reliever/fever reducer


Structured Label Content

Section 34088-5 (34088-5)

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 right away 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 42229-5 (42229-5)

"This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark Tylenol®

Distributed by C.D.M.A. lnc.

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Question: 800-935-2362

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if your child has liver disease

Section 55105-1 (55105-1)
  • 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.

When using this product do not  exceed recommended dose (see  overdose warning)

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 below.

If possible, use weight to dose; otherwise, use age.

  • only use enclosed measuring syringe
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours

    Weight (Ib)

    Age (yr)

    Dose (mL)

    or as directed by doctor

    Under 24

    Under 2 years

    Ask a doctor

    24-35

    2-3 years

    5 mL

Do Not Use (Do not use)
  • with any other drug containing acetaminophen (prescription or non-prescription). 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
Other Information (Other information)
  • store between 20° -25°c (68°-77 °F)
  • protect from freezing
  • protect from light

Questions or comments?

1-800-935-2362 (Mon-Fri 9am-5pm EST)

Uses Temporarily: (Uses temporarily:)
  • reduces fever
  • relieves minor aches and pains

due to:



  • the common cold
  • headache
  • flu
  • sore throat
  • toothache
Inactive Ingredients (Inactive ingredients)

acesulfame potassium, avicel, citric acid, FD&C blue no. 1, FD&C red no. 33, flavor, glycerine, high fructose corn syrup, polysorbate, propylene glycol, prosweet N & AK, purified water, sodium benzoate, sucralose, sorbitol, xanthan gum

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • new symptoms occur 
  • redness or swelling is present
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

Active Ingredient                         purpose (Active Ingredient                         Purpose)

Acetaminophen 160 mg ............... Pain reliever/fever reducer


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)