children's pain & fever, lil' drug store ®

children's pain & fever, lil' drug store ®
SPL v3
SPL
SPL Set ID 5fcd41ad-449f-4090-be19-eae4171de891
Route
oral
Published
Effective Date 2018-07-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (160 mg)
Inactive Ingredients
acesulfame potassium anhydrous citric acid butylparaben carboxymethylcellulose sodium, unspecified form fd&c red no. 40 glycerin high fructose corn syrup microcrystalline cellulose propylene glycol water sodium benzoate sorbitol xanthan gum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2014-12-01

Purpose

Pain reliever/fever reducer

Description

Drug Facts


Medication Information

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

Pain reliever/fever reducer

Directions
  • this product does not contain directions or complete warnings for adult use
  • do not take more than directed (see Overdose warning)
  • shake well before using
  • mL = milliliter
  • use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
Weight (lb) Age (year) Dose (mL)
or as directed by a doctor
under 24 under 2 ask a doctor
24-35 2-3 5 mL
36-47 4-5 7.5 mL
48-59 6-8 10 mL
60-71 9-10 12.5 mL
72-95 11 15 mL
Other Information
  • each 5 mL contains: sodium 2 mg
  • store between 20-25°C (68-77°F)
  • do not refrigerate
  • see bottom panel for lot number and expiration date
Inactive Ingredients

acesulfame potassium, butylparaben, carboxymethylcellulose sodium, citric acid, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol, xanthan gum

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product, do not exceed recommended dose (see Overdose warning).

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.

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
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.

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
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 (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

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.

Questions Or Comments?

Call toll free 1-877-507-6516 (M-F 8AM-4:30PM CST)

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 (in Each 5 Ml)

Acetaminophen 160 mg

Principal Display Panel 118 Ml Bottle Carton

QUALITY

* GUARANTEED *

Compare to the Active Ingredient

in Children's Tylenol®

Oral Suspension**

Children's

Pain & Fever

Acetaminophen

160 mg per 5 mL

Pain Reliever/Fever Reducer

Oral Suspension

For ages 2-11 years

Cherry

4 FL OZ (118 mL)

Lil'

Drug Store ®


Structured Label Content

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

Pain reliever/fever reducer

Directions
  • this product does not contain directions or complete warnings for adult use
  • do not take more than directed (see Overdose warning)
  • shake well before using
  • mL = milliliter
  • use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
Weight (lb) Age (year) Dose (mL)
or as directed by a doctor
under 24 under 2 ask a doctor
24-35 2-3 5 mL
36-47 4-5 7.5 mL
48-59 6-8 10 mL
60-71 9-10 12.5 mL
72-95 11 15 mL
Other Information (Other information)
  • each 5 mL contains: sodium 2 mg
  • store between 20-25°C (68-77°F)
  • do not refrigerate
  • see bottom panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

acesulfame potassium, butylparaben, carboxymethylcellulose sodium, citric acid, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol, xanthan gum

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product, do not exceed recommended dose (see Overdose warning).

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.

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 is allergic to acetaminophen or any of the inactive ingredients in this product
Allergy Alert (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.

Liver Warning (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
Overdose Warning (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 (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Sore Throat Warning (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.

Questions Or Comments? (Questions or comments?)

Call toll free 1-877-507-6516 (M-F 8AM-4:30PM CST)

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

Acetaminophen 160 mg

Principal Display Panel 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton)

QUALITY

* GUARANTEED *

Compare to the Active Ingredient

in Children's Tylenol®

Oral Suspension**

Children's

Pain & Fever

Acetaminophen

160 mg per 5 mL

Pain Reliever/Fever Reducer

Oral Suspension

For ages 2-11 years

Cherry

4 FL OZ (118 mL)

Lil'

Drug Store ®


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)