CORE VALUES PAIN AND FEVER

Main information

  • Trade name:
  • CORE VALUES PAIN AND FEVER- acetaminophen suspension
  • Composition:
  • ACETAMINOPHEN 160 mg in 5 mL
  • Administration route:
  • ORAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CORE VALUES PAIN AND FEVER- acetaminophen suspension
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Pain reliever/ fever reducer temporarily:

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph not final
  • Authorization number:
  • 63940-309-26
  • Last update:
  • 01-06-2019

Summary of Product characteristics: dosage, interactions, side effects

CORE VALUES PAIN AND FEVER- acetaminophen suspension

Harmon Stores 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.

----------

Harmon Stores Inc. Pain & Fever Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpos e

Pain reliever/fever reducer

Us es

temporarily:

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child

takes

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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

reduces fever

relieves minor aches and pains due to:

the common cold

headache

sore throat

toothache

more than 5 doses in 24 hours, which is the maximum daily amount

with other drugs containing acetaminophen

skin reddening

blisters

rash

with any other drug containing acetaminophen (prescription or nonprescription). If you are not

sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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

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

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

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

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

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

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

use any other dosing device.

Other information

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

Compare to active ingredient in Children’s Tylenol® Oral Suspension

For Ages 2 to 11 Years

Children’s Pain & Fever

Pain Reliever – Fever Reducer

Acetaminophen 160 mg per 5 mL Oral Suspension

Cherry Flavor

Aspirin Free

Ibuprofen Free

Alcohol Free

4 FL OZ (118 mL)

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

CORE VALUES PAIN AND FEVER

acetaminophen suspension

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 39 40 -30 9

Route of Administration

ORAL

Harmon Stores Inc.

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

16 0 mg in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

BUTYLPARABEN (UNII: 3QPI1U3FV8 )

CALCIUM SULFATE (UNII: WAT0 DDB50 5)

CARRAGEENAN (UNII: 5C6 9 YCD2YJ)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

GLYCERIN (UNII: PDC6 A3C0 OX)

HIGH FRUCTO SE CO RN SYRUP (UNII: XY6 UN3QB6 S)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SO DIUM PHO SPHATE, TRIBASIC (UNII: A752Q30 A6 X)

Product Characteristics

Color

RED (o paque)

S core

S hap e

S iz e

Flavor

CHERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 39 40 -30 9 -26

1 in 1 CARTON

11/0 6 /20 17

1

118 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

11/0 6 /20 17

Labeler -

Harmon Stores Inc. (804085293)

Revised: 8/2018