Your browser does not support JavaScript! CHILDRENS PLUS MULTI-SYMPTOM COLD GRAPE WITH PE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [DOLLAR GENERAL]
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CHILDRENS PLUS MULTI-SYMPTOM COLD GRAPE WITH PE (acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride) suspension
[Dollar General]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

Active Ingredients

Acetaminophen 160 mg
Chlorpheniramine maleate 1 mg
Dextromethorphan HBr 5 mg
Phenylephrine HCI 2.5 mg

Purposes

Acetaminophen...........................Pain reliever/fever reducer
Chlorpheniramine maleate..........Antihistamine
Dextromethorphan HBr..............Cough suppressant
Phenylephrine HCI......................Nasal decongestant

Uses

• temporarily relieves the following cold/flu
symptoms: • minor aches and pains • cough
• headache • sore throat • sneezing and runny nose
• stuffy 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

• 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.
• 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.

Ask a doctor before use if the child has

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

Ask a doctor or pharmacist before use if the child is taking

• sedatives or tranquilizers
• the blood thinning drug warfarin

When using this product

• do not exceed recommended dosage (see overdose warning)
• may cause excitability, especially in children
• marked drowsiness may occur • sedatives and
tranquilizers may increase drowsiness

Stop use and ask a doctor if

• new symptoms occur
• fever gets worse or lasts for more than 3 days
• redness or swelling is present
• pain, nasal congestion or cough gets worse or
lasts for more than 5 days
• nervousness, dizziness or sleeplessness occur
• cough comes back or occurs with rash or headache
that lasts. These could be signs of a serious
condition

Keep this and all drugs out of the reach of children.

Overdose Warning: Taking more than the
recommended dose (overdose) could cause serious
health problems, including liver damage. In case of
accidental overdose, seek professional assistance or
contact a Poison Control Center immediately. Quick
medical attention is critical even if you do not notice
any signs or symptoms.

Directions

• do not exceed recommended dosage
(see overdose warning) • shake well before using
• find right dose on chart below. If possible, use
weight to dose; otherwise, use age
• if needed, repeat dose every 4 hours while
symptoms last
• 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 tsps or 10 mL

Other Information

• dosage cup provided
• store at controlled room temperature

Inactive Ingredients

blue 1, carboxymethylcellulose sodium, cellulose,
citric acid, flavors, glycerin, purified water, red 33,
red 40, sodium benzoate, sorbitol, sucrose,
xanthan gum

Principal Display Panel

DOLLAR GENERAL
HEALTH SENSE
CHILDRENS PLUS MULTI SYMPTOM COLD
COMPARE TO ACTIVE INGREDIENTS IN CHILDREN'S TYLENOL
PLUS MULTI-SYMPTOM COLD
SEE NEW DOSING INFORMATION
4 FL OZ (118 ML)
GRAPE FLAVOR

image of label

CHILDRENS PLUS MULTI-SYMPTOM COLD GRAPE  WITH PE
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride suspension
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55910-145
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
CARBOXYMETHYLCELLULOSE SODIUM 
CELLULOSE, MICROCRYSTALLINE 
CITRIC ACID MONOHYDRATE 
GLYCERIN 
WATER 
D&C RED NO. 33 
FD&C RED NO. 40 
SODIUM BENZOATE 
SORBITOL 
SUCROSE 
XANTHAN GUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Grape Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-145-04118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/29/2009
Labeler - Dollar General (068331990)
Registrant - Aaron Industries, Inc. (101896231)
Establishment
NameAddressID/FEIBusiness Operations
Aaron Industries, Inc.101896231manufacture, analysis

Revised: 11/2009
 
Dollar General

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