Pain Relief Childrens: Package Insert and Label Information

PAIN RELIEF CHILDRENS- acetaminophen suspension
Publix Super Markets Inc

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
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 has ever had an allergic reaction to this product or any of its ingredients

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

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.

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.
remove the child protective cap and squeeze your child’s dose into the dosing cup
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours

Weight (lb)

Age (yr)

Dose (mL)*

under 24

under 2 years

ask a doctor

24-35

2-3 years

5 mL

36-47

4-5 years

7.5 mL

48-59

6-8 years

10 mL

60-71

9-10 years

12.5 mL

72-95

11 years

15 mL

*or as directed by a doctor

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

Other information

each 5 mL contains: sodium 3 mg
store at 20-25° C (68-77° F)
do not use if printed neckband is broken or missing

Inactive ingredients

anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, FD&C red #40, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate

Principal Display Panel

FOR AGES 2 to 11 YEARS

CHILDREN’S

pain relief

ACETAMINOPHEN 160 mg PER 5 mL

PAIN RELIEVER/FEVER REDUCER

ORAL SUSPENSION

FAST, EFFECTIVE RELIEF OF CHILDREN’S PAIN & FEVER

Ibuprofen free

Alcohol free

Aspirin free

CHERRY FLAVOR

Compare to Children’s Tylenol® Oral Suspension active ingredient

4 FL OZ (118 mL)

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(click image for full-size original)
PAIN RELIEF CHILDRENS
acetaminophen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:56062-175
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
CALCIUM SULFATE
CARRAGEENAN
FD&C RED NO. 40
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
CELLULOSE, MICROCRYSTALLINE
CARBOXYMETHYLCELLULOSE SODIUM
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SORBITOL
SODIUM PHOSPHATE, TRIBASIC
Product Characteristics
Color RED (opaque) Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:56062-175-26 1 BOTTLE in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (56062-175-26)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 08/28/2003
Labeler — Publix Super Markets Inc (006922009)

Revised: 10/2018 Publix Super Markets Inc

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