ACETAMINOPHEN- acetaminophen suspension

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
NuCare Pharmaceuticals,Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer temporarily: - reduces fever - relieves minor aches and pains due to: - the common cold - flu - headache - sore throat - toothache
Authorization status:
OTC monograph not final
Authorization number:
68071-4860-4

ACETAMINOPHEN- acetaminophen suspension

NuCare Pharmaceuticals,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.

----------

Perrigo Children’s Acetaminophen Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpos e

Pain reliever/fever reducer

Us es

temporarily:

reduces fever

relieves minor aches and pains due to:

the common cold

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

do not use if printed neckband is broken or missing

Inactive ingredients

anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor,

glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and

carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution,

tribasic sodium phosphate

Questions or comments?

1-800-719-9260

Principal Display Panel

ACETAMINOPHEN

acetaminophen suspension

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 0 71-48 6 0 (NDC:458 0 2-20 1)

Route of Administration

ORAL

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)

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

GLYCERIN (UNII: PDC6 A3C0 OX)

NuCare Pharmaceuticals,Inc.

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

purple (visco us)

S core

S hap e

S iz e

Flavor

GRAPE

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 0 71-48 6 0 -4

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

0 4/22/20 19

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

0 4/0 9 /20 14

Labeler -

NuCare Pharmaceuticals,Inc. (010632300)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

NuCare Pharmaceuticals,Inc.

0 10 6 3230 0

re la be l(6 8 0 71-48 6 0 )

Revised: 4/2019

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