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Childrens Plus Multi-Symptom Cold Grape with PE

Dosage form: suspension
Ingredients: ACETAMINOPHEN 160mg in 5mL, CHLORPHENIRAMINE MALEATE 1mg in 5mL, DEXTROMETHORPHAN HYDROBROMIDE 5mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 5mL
Labeler: Rite Aid Corporation
NDC Code: 11822-1434

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 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

Rite Aid Pharmacy

Compare to active ingredients in Tylenol

Children's Plus Multi-Symptom Cold Grape

acetaminophen- pain reliever and fever reducer

chlorpheniramine maleate- antihistamine

dextromethorphan HBr- cough suppressant

Phenylephrine HCI -nasal decongestant

4 fl oz (118mL)



CHILDRENS PLUS MULTI-SYMPTOM COLD GRAPE  WITH PE
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1434
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 Description
1NDC:11822-1434-4118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/11/2009
Labeler - Rite Aid Corporation (014578892)

Revised: 06/2017
 
Rite Aid Corporation

← See all Childrens Plus Multi-Symptom Cold Grape with PE brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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