Pain and Fever Relief Childrens: Package Insert and Label Information

PAIN AND FEVER RELIEF CHILDRENS- acetaminophen suspension
Cardinal Health (Leader) 70000

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily reduces fever
  • temporarily 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.

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 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.

When using this product,

do not exceed recommended dose (see Overdose warning)

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.

Keep out of reach of children.

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.

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 gve 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)
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 20-25ºC (68-77ºF)
  • do not refrigerate
  • see bottom panel for lot number and expiration date

Inactive ingredients

butylparaben, carboxymethylcellulose sodium, citric acid, D&C red #33, FD&C blue #1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Children’s

Pain & Fever

Acetaminophen

160 mg per 5 mL

Oral Suspension

Fever Reducer, Pain Reliever

Grape Flavor

Ages 2-11 Years

Aspirin Free

Alcohol Free

Ibuprofen Free

FL OZ (mL)

COMPARE TO CHILDREN’s TYLENOL® ORAL SUSPENSION active ingredient**

**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children’s Tylenol® Oral Suspension.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Product Label

Acetaminophen 160 mg
(click image for full-size original)

LEADER Children’s Pain & Fever

PAIN AND FEVER RELIEF CHILDRENS
acetaminophen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0173
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
BUTYLPARABEN
CARBOXYMETHYLCELLULOSE SODIUM
D&C RED NO. 33
FD&C BLUE NO. 1
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
CELLULOSE, MICROCRYSTALLINE
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SORBITOL
SUCRALOSE
XANTHAN GUM
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70000-0173-1 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
1 118 mL in 1 BOTTLE, PLASTIC This package is contained within the BOX (70000-0173-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 10/31/2016 12/31/2023
Labeler — Cardinal Health (Leader) 70000 (063997360)

Revised: 09/2021 Cardinal Health (Leader) 70000

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