DYE FREE PAIN AND FEVER CHILDRENS- acetaminophen suspension

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

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
Walgreens
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer - temporarily reduces fever - temporarily relieves minor aches and pains due to: the common cold flu headache sore throat toothache - the common cold - flu - headache - sore throat - toothache
Authorization status:
OTC monograph not final
Authorization number:
0363-0285-04

DYE FREE PAIN AND FEVER CHILDRENS- acetaminophen suspension

Walgreens

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.

----------

Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpos e

Pain reliever/fever reducer

Us es

temporarily reduces fever

temporarily 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 you 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 non-prescription). 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 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)*

under 24

under 2

ask a doctor

24-35

5 mL

36-47

7.5 mL

48-59

10 mL

60-71

9-10

12.5 mL

72-95

15 mL

*or as directed by a doctor

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

anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, flavor, 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

Compare to Children's Tylenol® Oral Suspension active ingredient††

children's

Dye-Free

Pain & Fever

ACETAMINOPHEN 160 mg PER 5 mL

PAIN RELIEVER /

FEVER REDUCER

ORAL SUSPENSION

DYE FREE

ASPIRIN FREE

IBUPROFEN FREE

ALCOHOL FREE

AGES 2 - 11 YEARS

FL OZ (mL)

GRAPE FLAVOR

DOSAGE CUP PROVIDED

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY

SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

††This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of

Children's Tylenol® Oral Suspension.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

Product Label

WALGREENS Childrens Dye-Free Pain & Fever

DYE FREE PAIN AND FEVER CHILDRENS

acetaminophen suspension

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 36 3-0 28 5

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

Walgre e ns

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

BUTYLPARABEN (UNII: 3QPI1U3FV8 )

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

GLYCERIN (UNII: PDC6 A3C0 OX)

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

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

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)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics

Color

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:0 36 3-0 28 5-

1 in 1 BOX

0 3/31/20 15

1

118 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part343

0 3/31/20 15

Labeler -

Walgreens (008965063)

Revised: 3/2019

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