CHILDRENS PAIN RELIEF COLD AND FLU- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspension

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

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
Rite Aid Corporation
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant
Authorization status:
OTC monograph final
Authorization number:
11822-1023-1

CHILDRENS PAIN RELIEF COLD AND FLU- acetaminophen, chlorpheniramine maleate,

dextromethorphan hbr, phenylephrine hcl suspension

Rite Aid Corporation

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.

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Rite Aid Corporation Children’s Pain Relief Cold & Flu Drug Facts

Active ingredients (in each 5 mL)

Acetaminophen 160 mg

Chlorpheniramine maleate 1 mg

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Purpos e

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Us es

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:

temporarily relieves the following cold/flu symptoms:

minor aches and pains

headache

sore throat

sneezing and runny nose

cough

stuffy nose

temporarily reduces fever

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

with other drugs containing acetaminophen

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

Ask a doctor before use if your child has

Ask a doctor or pharmacist before use if your child is

When using this product

Stop use and ask a doctor if

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

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

to make a child sleepy

in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for

depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after

stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI,

ask a doctor or pharmacist before giving this product.

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

liver disease

heart disease

high blood pressure

thyroid disease

diabetes

glaucoma

persistent or chronic cough such as occurs with asthma

cough that occurs with too much phlegm (mucus)

a breathing problem such as chronic bronchitis

taking the blood thinning drug warfarin

taking sedatives or tranquilizers

do not exceed recommended dosage (see overdose warning)

excitability may occur, especially in children

marked drowsiness may occur

sedatives and tranquilizers may increase drowsiness

nervousness, dizziness or sleeplessness occur

pain, nasal congestion or cough gets worse or lasts more than 5 days

fever gets worse or lasts more than 3 days

redness or swelling is present

new symptoms occur

cough comes back or occurs with rash or headache that lasts. 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 36

under 4 years

do not use

36-47

4 to 5 years

do not use unless directed by a

doctor

48-95

6 to 11 years

10 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

Inactive ingredients

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

FD&C red #40, flavor, glycerin, polysorbate 80, purified water, sodium benzoate, sorbitol solution,

sucrose, tribasic sodium phosphate, xanthan gum

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the active ingredients of Children’s Tylenol

Cold + Flu Oral Suspension

FOR AGES 6-11 YEARS

CHILDREN’S PAIN RELIEF COLD & FLU

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

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

ACETAMINOPHEN

PAIN RELIEVER/FEVER REDUCER

CHLORPHENIRAMINE MALEATE

ANTIHISTAMINE

DEXTROMETHORPHAN HBr

COUGH SUPPRESSANT

PHENYLEPHRINE HCl

NASAL DECONGESTANT

oral suspension

relieves fever, sore throat, sneezing, runny nose, cough, and stuffy nose

alcohol free - aspirin free

ibuprofen free – gluten free

GRAPE FLAVOR

DOSAGE CUP INCLUDED

4 FL OZ (118 mL)

CHILDRENS PAIN RELIEF COLD AND FLU

acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspension

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:118 22-10 23

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

CHLO RPHENIRAMINE MALEATE (UNII: V1Q0 O9 OJ9 Z) (CHLORPHENIRAMINE -

UNII:3U6 IO 19 6 5U)

CHLORPHENIRAMINE

MALEATE

1 mg

in 5 mL

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

5 mg

in 5 mL

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

2.5 mg

in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

CALCIUM SULFATE (UNII: WAT0 DDB50 5)

CARRAGEENAN (UNII: 5C6 9 YCD2YJ)

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

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

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

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

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

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

SUCRO SE (UNII: C151H8 M554)

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

XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics

Color

PURPLE

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:118 22-10 23-1

1 in 1 CARTON

0 7/26 /20 19

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 final

pa rt341

0 7/26 /20 19

Rite Aid Corporation

Labeler -

Rite Aid Corporation (014578892)

Revised: 9/2019

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