PLUS MULTI SYMPTOM COLD CHILDRENS PAIN RELIEF- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspension 
Hannaford Brothers Company

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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Hannaford Bros. Co. Children's Pain Relief Plus Multi-Symptom Cold Drug Facts

Active ingredient (in each 5 mL = 1 teaspoon)

Acetaminophen 160 mg

Chlorpheniramine maleate 1 mg

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Purpose

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Uses

temporarily relieves the following cold/flu symptoms:
minor aches and pains
headache
sore throat
cough
nasal congestion
sneezing and runny nose
temporarily reduces fever

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

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

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.
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

Ask a doctor before use if the child has

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
persistent or chronic cough such as occurs with asthma
cough that occurs with too much phlegm (mucus)
a breathing problem such as chronic bronchitis
glaucoma

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers
taking the blood thinning drug warfarin

When using this product

do not exceed recommended dosage
excitability may occur, especially in children
marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

nervousness, dizziness or sleeplessness occurs
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.

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 Liver warning)
shake well before using
find right dose on chart. If possible, use weight to dose; otherwise use age.
use only with enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
if needed, repeat dose every 4-6 hours
do not give more than 5 times in 24 hours

Weight(lb)

Age(yr)

Dose (tsp or mL)

under 36

under 4

do not use

36-47

4-5

do not use unless directed by a doctor

48-95

6-11

2 tsp or 10 mL

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

Other information

each teaspoon contains: sodium 3 mg
store at 20º-25ºC (68º-77ºF)
do not use if printed neckband is broken or missing

Inactive ingredients

carrageenan, citric acid, D&C red no. 33, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, polysorbate 80, purified water, sodium benzoate, sorbitol, sucrose, xanthan gum

Questions or comments?

1-800-213-9040

Principal Display Panel

Compare to Children’s Tylenol® Plus Multi-Symptom Cold active ingredients

Fever Reducer/Pain Reliever

Cough Suppressant

Nasal Decongestant

Antithistamine

See New Warnings Information

Children’s Pain Relief

Plus Multi-Symptom Cold

Contains 4 Ingredients:

Fever & Sore Throat – Acetaminophen

Cough – Dextromethorphan HBr

Stuffy Nose – Phenylephrine HCl

Sneezing & Runny Nose – Chlorpheniramine Maleate

Grape Flavor

Oral Suspension

Children's Pain Relief Plus Multi-Symptom Cold Carton Image 1

Children's Pain Relief Plus Multi-Symptom Cold Carton Image 1

Children's Pain Relief Plus Multi-Symptom Cold Carton Image 2

Children's Pain Relief Plus Multi-Symptom Cold Carton Image 1

Children's Pain Relief Plus Multi-Symptom Cold Carton Image 2

PLUS MULTI SYMPTOM COLD  CHILDRENS PAIN RELIEF
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41268-903
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CARRAGEENAN (UNII: 5C69YCD2YJ)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorPURPLE (opaque) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41268-903-261 in 1 CARTON10/29/200805/26/2012
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/29/200805/26/2012
Labeler - Hannaford Brothers Company (006949556)

Revised: 11/2017
 
Hannaford Brothers Company