5b8a92c9-47c0-4438-a49d-b3878f7afd73

SPL v6
SPL
SPL Set ID 5b8a92c9-47c0-4438-a49d-b3878f7afd73
Route
oral
Published
Effective Date 2022-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (160 mg)
Inactive Ingredients
acesulfame potassium microcrystalline cellulose anhydrous citric acid fd&c red no. 40 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

Purpose

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

Description

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


Medication Information

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if your child takes 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
  • blister
  • 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.

Uses

temporarily:

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

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

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= millilitar
  • 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

Other Information
  • store between 20°-25°C (68°-77°F)
  • protect from freezing
  • protect from light

Questions or comments?

Call toll free 619-600-5632

Monday through Fnday 9AM - 5PM EST

Inactive Ingredients

acesulfame potassium, avicel, citric acid, FD&C red no. 40, flavor, glycerine, high fructose corn syrup, polysorbate, propylene glycol, prosweet N&AK, purified water, sodium benzoate, sucralose, sorbitol, xanthan gum.

Description

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

Principal Display Panel

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

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

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if

  • new sympthoms 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

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

Do Not Use
  • with any other drug containing acetaminophen (prescnption 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.
Active Ingredient(in Each 5ml) Purpose

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


Structured Label Content

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if your child takes 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
  • blister
  • 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.

Uses

temporarily:

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

Other Information (Other information)
  • store between 20°-25°C (68°-77°F)
  • protect from freezing
  • protect from light

Questions or comments?

Call toll free 619-600-5632

Monday through Fnday 9AM - 5PM EST

Inactive Ingredients (Inactive ingredients)

acesulfame potassium, avicel, citric acid, FD&C red no. 40, 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)

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)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • new sympthoms 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

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

Do Not Use (Do not use)
  • with any other drug containing acetaminophen (prescnption 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.
Active Ingredient(in Each 5ml) Purpose (Active Ingredient(in each 5mL) Purpose)

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


Advanced Ingredient Data


Raw Label Data

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